Modular Prosthetic Sockets and Method for Making Same

ABSTRACT

A prosthetic socket for a residual limb of the lower extremity or upper extremity of an individual person is provided. The residual limb has particular dimensions and anatomical contours; the prosthetic socket has dimensions and contours that fit the dimensions and contours of the residual limb. The prosthetic socket may also fit in a manner that is biomechanically appropriate for the individual. The prosthetic socket may be an assembly from groups of components that include (a) struts arranged longitudinally with respect to the residual limb, (b) proximal brim members arranged proximally to the struts and connected thereto; and (c) distal socket members disposed at the distal base of the prosthetic socket. The socket components within these groups may be modular in that they can vary with respect to dimensions and/or contours, and yet have common connecting features that permit assembly of the components together to form the prosthetic socket.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Ser. No. 15/410,149, filedJan. 19, 2017, which is a continuation of U.S. Ser. No. 14/798,295,filed Jul. 13, 2015, now issued as U.S. Pat. No. 9,549,828, which is acontinuation of U.S. Ser. No. 14/659,433, filed Mar. 16, 2015, and is acontinuation of U.S. Ser. No. 13/675,761, filed Nov. 13, 2012, now U.S.Pat. No. 8,978,224, which claims the benefit of U.S. Provisional PatentApplication No. 61/559,051, filed on Nov. 12, 2011, all of which arehereby incorporated by reference in their entireties herein.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present invention relates to the field of prosthetics and orthotics.More particularly, the present invention relates to prosthetic socketsthat are part of a prosthesis that is made to fit the residual limb ofan amputee.

2. State of the Art

Current prosthetic limbs for the upper and lower extremity typicallyinclude a residual limb socket, an alignment system, and a functionalcomponent such as a knee, foot, or hand. For any prosthetic limb, aprosthetic socket is the portion of the prosthesis that is designed tofit and interface the residual limb with the rest of the prostheticcomponents. The socket is the structural component of the prosthesisthat contains the residual limb, and provides connection to the othercomponents. The prosthetic socket is an important part of the prostheticlimb; if it does not operate properly, utility of the distal componentscan be severely compromised.

Positive and negative molds of the residual limb typically play acentral role in the making a residual limb prosthetic socket. Forexample, after a professional prosthetist has fully evaluated apatient's condition and needs, the prosthetist casts a negative mold ofthe residual limb using plaster or fiberglass casting tape. Thisnegative mold is filled with Plaster of Paris and allowed to harden. Thenegative cast is then peeled off to reveal the newly formed positivemold. This positive mold may then modified by the prosthetist in anattempt to create a positive form that supports the creation of a limbsocket that distributes pressure optimally on the residual when thesocket is worn. The actual prosthetic socket is then fabricated overthis positive mold. The positive mold is broken and removed from thefabricated socket, and the prosthetic socket may then be cut or furthermodified to fit its intended location and buffed.

In addition to the aspects of fabrication process just described,additional steps of the fabrication process may include making andintegrating flexible inner liners, locking mechanisms, alignmentmechanisms, and other components to create the final prosthetic socketproduct.

When complete, the socket is typically tested on the patient for fit andfor the patient's subjective sense of how it feels. In spite ofmodifications that are possible, and in spite of level of optimizationmade possible by liners and locking and alignment mechanisms, the form,as provided by the positive mold and as reflected in the resultantsocket dominate variables associated with the fit of the socket andpatient satisfaction. By this conventional fabrication approach, thedegree of possible modification of the limb socket to optimize the fitof the residual limb socket is actually quite limited. Accordingly, itis common practice to make a number of “check sockets” or “diagnosticsockets” from which the best option is chosen as the final product forthe patient.

As may be understood from the foregoing brief summary of a conventionalprosthetic fabrication process, there are aspects of the process thatare less than satisfactory, largely associated with the centrality ofphysical molds within the process that transfer size and shapeinformation from the residual limb that is reflected in the finalprosthetic socket product. The process is drawn out and time consuming,and inexact. And the product, when formed and however satisfactory, issubstantially fixed in form, and not readily modifiable. The residuallimb, itself, is not fixed in form, and may vary in shape and conditionwith time as the patient ages, and as the residual limb changes inresponse to use and environmental conditions. Developments in the fieldthat could improve these shortcomings would be welcome in the medicalmarket, particularly in areas of the developing world where patientswith amputated limbs are medically underserved and resources arelimited.

SUMMARY OF THE INVENTION

The disclosed technology, as summarized below, relates to a prostheticsocket for the residual limb of a person who has had an amputation of aportion of an extremity. A prosthetic socket is a structure that engagesthe residual limb, and provides a functional base for other components,to build out a more complete a prosthetic apparatus. Embodiments of thetechnology relate to the prosthetic socket structure, to systems andkits from which a prosthetic socket can be assembled, to larger systemsor devices that include the prosthetic socket, and to methods of makinga prosthetic socket.

Embodiments of the invention may include any one or more particularaspects. For example, embodiments may include a modular aspect, whereinthe prosthetic socket includes, and may be assembled from modularcomponents. Modularity generally refers to component parts that havefeatures that vary in dimension or shape, but nevertheless haveattachment features in common that provide compatibility for assembly ofcomponents into a prosthetic socket. Modularity also generally refersaspects of assembling a prosthetic socket, wherein modularity providesvariation in dimensions or shape from parts that are interchangeablewithin the specific component types. The interchangeability aspect ofmodularity also relates to repair, or reconfiguration of an assembleddevice, simply by switching components in and out. Accordingly,embodiments of the assembled sock can vary in dimensions and shape, andfurther are accompanied by these capabilities of repair andreconfiguration.

Some embodiments of the invention relate to a direct-fitting method ofselecting and manipulating component parts such that the assembledsocket substantially fits the residual limb of the person who has hadthe amputation, and who will be wearing the socket. Direct fitting is aterm of art that is generally understood as excluding the use of moldsin a fitting process. Casting of physical forms and the use of molds toreplicate forms or create complementary forms relate to the use ofintervening physical forms to transfer information about dimension andshape. Direct fitting involves methods that transfer measurements ormaps of dimension and shape directly to the fabrication of replicateobjects or complementary objects, such as a socket that is complementaryto a residual limb.

Some embodiments of the invention may include an aspect of fitting thatrelates to more than simple fitting with regard to a static version ofsize and shape. Embodiments of the invention take into considerationaspects of the movement and physical activity that are particular to theindividual, as may be habits of the person. Some body movements mayrelate to types of daily activity that the individual engages inhabitually, or wishes to continue to engage in. These considerationsrelate to direct fitting that is biomechanically appropriate for theindividual. By way of a simple example, the residual limb of an athlete,a sedentary person, or an elderly person, may all be very similar insize and shape, and yet the biomechanics associated with theserespective residual limbs can be very different. Direct fitting, in thiscontext and merely by way of example, may thus include measurements ofdimension and shape of the residual limb through a range of motion, orunder conditions of bearing weight, or in situations where the body ofthe individual is in varied positions. Aspects of such fitting mayfurther include considerations of biological structure underlying thesuperficial aspects of dimension and form. By way of example, thebiomechanics of soft tissue, or injured tissue, or bone and cartilageare different, particularly with regard to the ways in which thesetissues respond to pressure, as may be imparted by embodiments of theprosthetic socket on the residual limb. These various considerations inthe context of direct fitting may be referred to as dynamic fitting, orbiomechanically appropriate fitting.

Some embodiments of the invention may include adjustability ofdimensions or shape and contours of the prosthetic socket. Adjustabilityis advantageous in several aspects. For example, the residual limb is aliving structure that can change in dimension or shape over time. Suchchanges can occur even in short periods of time, such as during a day,or according to the physical position of the individual, or whether theindividual is walking or sleeping. In another time-related example, ifthe individual to be wearing the prosthetic socket is still a growingchild or adolescent, the dimensions, shape, and biomechanical demandswill definitely be changing. Similarly, of course, dimensions, shape,and biomechanical considerations change as an individual may bephysically declining with age or due to health issues. Adjustability canaccommodate such changes.

In another example, dimensions or shape or biomechanical demands canchange according to the activity of the person. Further still, thesubjective sense of what is comfortable for the person may change, evenin the absence of physical change in dimension or form. Accordingly,capabilities and mechanisms of adjustment are attributes of someembodiments of the prosthetic socket. Such adjustability may include thedimensions or shape of the prosthetic as a whole, potentially involvingmore than one component of the socket. And in some embodiments,adjustability may relate more particularly to adjustability features ofparticular components, which, in turn, manifest as adjustable aspects ofthe prosthetic socket as a whole.

Turning now to embodiments to summarize in further detail, oneparticular embodiment relates to a modular prosthetic system thatincludes a prosthetic socket for a residual limb of an individualperson, the residual limb having individual dimensions and anatomicalcontours, the prosthetic socket having dimensions and contours thatsubstantially fit the dimensions and contours of the residual limb, theprosthetic socket including an assembly of components from each of threegroups of socket components. These groups of socket components include(a) one or more struts arranged longitudinally with respect to theresidual limb, each strut having a distal end and a proximal end, (b)one or more proximal brim members arranged proximally with respect tothe one or more struts and connected directly or indirectly thereto, and(c) one or more distal socket members disposed at the distal base of theprosthetic socket. One or more of these socket component groups includemodular components, the modular components having (1) variation withrespect to dimensions and/or contours and (2) common connecting featuresthat permit assembly of the components from the three groups ofcomponents together to form the prosthetic socket.

While these three particular groups of components are recited asexamples of the invention, the scope of the invention includes othercomponents, and any prosthetic socket component, including anyparticular component or accessory element associated with the prostheticsocket that can be modular in the sense that is described herein. And,particularly included within the scope of this invention is anyprosthetic socket member, or component, or associated apparatus that isdescribed or depicted herein.

Detailed aspects of this first particular embodiment will be elaboratedon below. Following that, other embodiments will be summarized asalternative embodiments that may also include all of the featuressummarized in the context of the first embodiment.

In some embodiments of the invention, when the individual person forwhom the prosthetic socket is intended engages or desires to engage in arange of daily activities, the dimensions and contours of the socket maybe further selected, configured, or modified so as to be biomechanicallyappropriate in the context of the daily activities of the person.

Whereas the embodiment above is summarized as having one or more of thegroups of the three groups components including components that aremodular in nature, in other embodiments, either two of the three groups,or all of the three groups may be modular in nature. Modular, in thiscontext, refers to having common attachment or connecting featuresdespite having variation in dimension or shape. These variable aspectswith regard to dimension or shape may be selected either on the basis offitting the dimension and shape of the residual limb, or on aspects ofthe dimension and shape of the residual limb as the limb may assume whenin motion or generally engaging in biomechanical dynamics associatedwith activities of daily living.

Some embodiments of a prosthetic socket system may include an inventoryof components for each of the groups of components that are modular; thecomponents that are selected for contributing to the assembly of afinished prosthetic socket may be selected from such inventories. Asrecited elsewhere, embodiments of the prosthetic socket system mayinclude further components or accessory mechanisms that, like the threeparticular groups of components recited, are also modular. Accordingly,such other modular components participate in the invention by way ofbeing deliverable from inventories of such components. Any componentincluded in the assembly of a prosthetic socket, as provided herein, isincluded in the scope of the invention, particularly any component thatis directly associated or interactive with any of the three particulargroups of components recited. Further particularly included is anycomponent or any member of a prosthetic socket that is described ordepicted herein.

Typically, the components selected from an inventory of components forassembly into the prosthetic socket are selected by a direct fitapproach. The criteria for selecting by a direct fit approach are tooptimize the fit of the assembled prosthetic sock with respect to thedimensions and contoured aspects of the residual limb, and the criteriamay further include optimization of the biomechanical appropriateness ofthe assembled prosthetic socket.

Inventories, as embodied by the invention, may include collections orkits of immediately available components, or the inventory may haveon-demand nature, such that when a desired component is not immediatelyavailable, it can nevertheless be ordered or fabricated, as needed.

In various embodiments of the prosthetic socket system, the modularcomponents from any of the three groups of modular components, as may beprovided by inventories, may be any of a prefabricated component havingvarious attributes regarding the nature of their from, whether its fixedor changeable. Accordingly, prefabricated prosthetic socket componentsmay be any of, or any combination of standardized or substantially fixedform, a custom-fabricated or custom-molded component, a malleable ormechanically reformable or modifiable component, a component having anadjustable aspect of dimension or contour, or a component having aphase-changing composition that provides alternative dimensions, shape,or material propertied according to phase.

Some of these recited types of prefabricated components may be modifiedbefore being included in the assembly of a prosthetic socket. Withregard to any aspect of dimension or shape, of any of the modularcomponents that is modified so as to fit the dimensions or shape of thecomponents of the residual limb, such modification may occur by way of adirect fit process.

As recited elsewhere, the scope of the invention as it relates to thesevarious fixed form vs. changeable form attributes of components used inthe assembly of a prosthetic socket include components beyond the threeparticular examples of modular components described and depicted herein.Further, while these attributes of components are being related here interms of their assembly, such attributes also relate to repair andreconfiguration. Further, while changes in dimension or shape are beingrelated in the context of component changes prior to assembly of thesocket, at least some of such changeable aspects of shape or dimensionthat may occur after assembly of the components into the full prostheticsocket.

In various embodiments of the prosthetic socket system, as justreferenced, various dimensions or contours of the prosthetic socket maybe adjustable. With regard to dimensions, for example, any of length,width, circumference, or volume may be adjustable. With regard to shape,any aspect of shape may be adjusted, such as contours or angulations,merely by way of example.

In various embodiments of the prosthetic socket system the adjustabledimensions or contours of the prosthetic socket may occur by way ofmechanisms or approaches that affect the dimensions or shape of theassembled prosthetic socket as a whole. In other embodiments, theadjustability of dimension or shape of the prosthetic socket occurs byway of adjustment or adjustments made particularly to any one or more ofthe components as selected from the groups of modular socket components.

In various embodiments of the prosthetic socket or the modularcomponents thereof, adjustability can be performed either by a person,such as a prosthetist, or such the individual person for whom theprosthetic socket is intended. Adjustments may be made to the prostheticsocket while the socket is being worn, or when it is removed and moreeasily manipulated. In other embodiments, adjustability may occurautomatically, or with mechanical assistance. In some embodiments, theprosthetic socket includes a microprocessor in operable association withan adjustability mechanism; in these embodiments the adjustabledimensions or contours of the prosthetic socket may be operablyadjustable by the microprocessor and associated mechanism.

The prosthetic socket may be understood to provide a volume in which theresidual limb is accommodated. The volume is encompassed within acircumferential area internal to the struts, a distal boundary accordingto the distal base of the socket, and a proximal boundary according tothe proximal ends of the struts. In some embodiments of the prostheticsocket, such volume may adjustable, either by adjusting dimensions,shape, or a combination thereof.

In some embodiments of the prosthetic system, a prosthetic socketcomponent comprises a moldable composition that may be adjusted orreformed. In typical embodiments that are adjusted or reformed, suchchanges may be made by a method comprising direct molding of thecomponent against at least a portion of the residual limb. Merely by wayof example, such component may be moldable by way of heat sensitivelability or by curing, in order to stabilize the molded form.

As referenced above, embodiments of the prosthetic socket may be sized,shaped, or adjusted so as to be biomechanically appropriate both for theresidual limb, itself, but more generally for the activities of theperson, or for particular aspects of anatomy and tissue that underliethe superficial aspects of residual limb dimension or shape. In someembodiments of the prosthetic socket, biomechanical considerationsparticularly concern the distribution of pressure against the residuallimb in a controlled manner when the prosthetic socket is being worn bythe individual

Accordingly, in some embodiments the pressure from the prosthetic socketon the limb may be distributed with substantial evenness across aninterfacing region between the prosthetic socket and a portion of theresidual limb, when the residual limb is disposed within the socket. Inother embodiments, the pressure from the prosthetic socket on the limbmay be distributed preferentially toward one or more particular localeswithin an interfacing region between the prosthetic socket and a portionof the residual limb, when the residual limb is disposed within thesocket. In any of these embodiments that relate to distribution ofpressure by the socket against the residual limb in a controlled andbiomechanically appropriate manner, a pressure distribution profile mayadvantageously take into account the range of activities of dailyliving.

Some embodiments of the prosthetic socket further include a flexibleliner arranged to be internal to arranged to line an interior aspect ofthe socket, such interior aspect including interior aspects of any ofthe prosthetic sockets structural weight bearing components, as forexample proximal brim member, the struts, or the distal members. Whenthe prosthetic socket is worn by the person, the liner thus represents asurface across which pressure is mutually transferred between theprosthetic socket and the residual limb. In a typical instance and inthe absence of an intervening liner, the structural weight bearingcomponents provide the initial locus of pressure impinging on theresidual limb from the prosthetic socket. In some embodiments, theflexible liner possesses sufficient stiffness and resilience that it cansupport distribution of at least some pressure across its surface, awayfrom the struts or other structural weight bearing components. In someof these embodiments, the flexible liner has sufficient stiffness andresilience that it can support distribution of pressure with substantialuniformity across its surface.

Some embodiments of the prosthetic socket include an external weightbearing surface, the external surface comprising external aspects of anyof the proximal brim member, the struts, or the distal member. Inparticular embodiments, the external weight-bearing surface hassufficient stiffness and resilience that it can support distribution ofat least some pressure across its surface, away from the structuralweight bearing components. In some of these embodiments, the externalweight-bearing surface has sufficient stiffness and resilience that itcan support distribution of pressure with substantial uniformity acrossits surface.

In some embodiments of the prosthetic socket, the one or more distalsocket members disposed at the distal base of the prosthetic socketinclude a socket cup disposed within the distal base, the socket cupconfigured to support a distal end of the residual limb. As with otherdistal members or elements of the prosthetic socket, the distal cup maybe modular in every sense of modularity recited elsewhere.

With regard to embodiments of prosthetic socket and its applicabilityand positioning on a residual limb when the socket is being worn by theindividual person, a distal end of the amputated limb is supported by adistal socket member, a distal portion of the residual limb is supportedby or within the one or more struts, and the portion of the residuallimb proximal to the portion embraced or supported by the struts issupportably enclasped by the proximal brim.

Embodiments of the prosthetic socket are adaptable to a residualpost-amputation portion of any of both an upper extremity or a lowerextremity. With regard to an upper extremity, a residual post-amputationportion of the upper extremity may be at an above-elbow arm (transhumeral) site or a below-elbow (trans-radial) arm site. With regard to alower extremity, a residual post-amputation portion of the lowerextremity may be at an above-knee (trans-femoral) leg site or abelow-knee (trans-tibial) leg site. Basically, embodiments of theprosthetic device may be adaptable to any conventional site ofamputation, at any level. Further, embodiments of the prosthetic devicemay be adaptable for use as any of an immediate post-operative socket, adiagnostic socket, a temporary socket, or a definitive socket.

In various embodiments of the prosthetic socket, components from any ofthe three recited groups of socket components (distal members, struts,proximal brim members), and any other component of the prosthetic socketmay include a shock-absorbing material. By way of example, oneparticular material is low durometer silicone.

A common problem for prosthetic sockets, in general, relates to theaccumulation of moisture that originates from the surface of theresidual limb. Such moisture can be irritating or uncomfortable to thewearer of the socket, or worse, it can contribute to sores, and it maygenerally compromise functionality of the prosthetic system.Accordingly, some embodiments of the prosthetic socket may include amoisture management or evacuation system. Aspects of a moistureevacuation system may be included in any portion or any component of theprosthetic socket, including, in particular components from any of thethree recited groups of components (distal member, struts, proximal brimmembers).

Examples of moisture evacuation systems included in the scope of theinvention include any one or more of a roll-on gel liner with integratedvertical moisture wicking channels, proximal internal and externalseals, moisture expulsion valves, and a locking mechanism with anintegrated moisture evacuation route.

As recited above, embodiments of the prosthetic socket may have a singlestrut, however other embodiments include a plurality of struts such astwo or three, or more. Some particular embodiments include four struts.Struts, if plural, are typically arranged circumferentially around acentral space that the residual limb occupies when the individual iswearing the prosthetic socket. Embodiments of the invention include anypractical or biomechanically advantageous spatial arrangement of thestruts. In some embodiments, the struts are evenly spaced apart. In someembodiments, the struts are arranged in a symmetrical manner, and insome embodiments, struts are arranged in an overlapping manner.

The distal ends of the struts are typically arranged to support distalmembers of elements of the prosthetic socket. In some embodiments, thestruts are mutually convergent at their distal ends, and joined to forma distal base of the prosthetic socket. In other embodiments, the strutsdo not converge themselves, but they support a distal base including oneor elements, such as a distal cup.

The surfaces of strut embodiments can interface directly with theresidual limb, although in some embodiments flexible liners may bedisposed within internal aspect of the socket, thereby interveningbetween the struts and the residual limb. By any arrangement, however,it is advantageous for the struts to present tissue-friendly,non-irritating or non-injurious, or biomechanically appropriate surfacethat will abut residual limb tissue when the socket is being worn.According, and merely by way of example, struts may include any one ormore of an oval-shaped cross section, rounded edges, or a surface thatis convex with respect to the residual limb surface.

In some embodiments of the prosthetic socket system, any one or more themodular prosthetic socket components may include features that provideadjustability to dimensions or shape, such as, merely by way of example,in any of length, height, width, curvature, contoured aspects,conformability, flexibility, rigidity, durometer, elastic modulus,positional orientation, and angulation.

In some embodiments, adjustability is provided by a mechanical apparatusor arrangement of interacting elements. One particular mechanicalarrangement may include a telescoping mechanism that can affect strutlength or width. In some embodiments, adjustability mechanisms mayinclude gearing features, cam elements, or movable wedges.

Some embodiments of the prosthetic system may include one or moreencircling bands around the struts or around the brim members, assummarized further elsewhere. These encircling bands can provide arelatively static support roll, in which they stabilize or secure thestruts or any structural component, contributing to the overallstructural integrity of the prosthetic socket, or they provide a moreactive adjustable role. Adjustments provided by an encircling band mayinclude adjustments to the circumference of the socket, or moreparticularly to the circumference described by the struts.Alternatively, inasmuch as the encircling bands can be elastic ortensionable, the encircling bands can adjust tension imparted to thestruts even in the absence of noticeable change in circumference.

In various embodiments of the prosthetic socket, one or more of theadjustable aspects of any structural component may manually operable,such operability available either to the person wearing the prostheticsocket or to a prosthetist working with the person. Adjustments may bemade either when the prosthetic socket is being worn, or when it is notbeing worn by the person.

In other embodiments of the prosthetic socket, one or more of theadjustable aspects of any structural component may be automaticallyoperable. Automatic, in this context, refers to the participation orfacilitation of adjustment by any non-manual approach, includingadjustments facilitated by microprocessors, or by material propertiesthat confer adjustability. Accordingly, some strut embodiments areoperably adjustable by a microprocessor and an associated adjustmentmechanism.

In other embodiments, a strut may be adjustable by changes that occur inphase change materials incorporated in the strut. Merely by way ofexample, phase change properties may elate to any one or more ofdurometer, rigidity or elasticity, electrically catalysable changes,light activatable changes, chemically-catalysable changes, ortemperature-related changes.

As noted above, some embodiments of a prosthetic socket may include oneor more encircling bands arranged around and connected to any prostheticsocket component, as for example, the struts or proximal brim members.In some embodiments, an encircling band is arranged and adapted so as toapply pressure radially inward on the struts. In some embodiments, thecircumference or tension of an encircling band is adjustable. In variousof these embodiments, an adjustment of the circumference or tension ofthe encircling band is operable to adjust a shape or contour of theprosthetic socket.

Some embodiments of the prosthetic socket the socket include two or moreencircling bands arranged around and connected to the longitudinalstruts, and the socket includes at least one tensioning band connectingthe at least two encircling bands, as for example, in an interlacedmanner. In such embodiments, the two or more bands may be arranged in alongitudinally spaced apart relationship, and the interlaced tensionbands may be arranged to stabilize that spaced apart relationship.Further, in some embodiments that include tensioning bands associatedwith either the struts or the encircling bands, tension bands areadjustable such that the tension they provide is adjustable.

Some embodiments of the modular prosthetic system, in addition to theprosthetic socket as extensively described herein, may further include adistal operable prosthetic element connected to the distal base of theprosthetic socket. Such operable prosthetic element may be of any typeknown in the art, such as wherein any of a prosthetic elbow, aprosthetic hand, a prosthetic knee, or a prosthetic foot.

Some embodiments of the modular prosthetic system, in addition to theprosthetic socket itself, may further include a suspension mechanism orrigging for the socket that is configured and arranged to supportmaintenance of the prosthetic device on the residual limb. Embodimentsof the suspension system may be generally of any conventional type knownin the art. The suspension systems may also be understood as modular innature, in that in spite of variations in form or structure, theyinclude attachment features that have substantial commonality orsufficiently flexibility that they can be operably attached to theprosthetic socket.

In some prosthetic system embodiments that particularly include asuspension rigging or mechanism, the system includes an inventory ofsuch mechanisms or riggings, from which an embodiment appropriate forthe individual may be selected. As with other modular aspects of theprosthetic system, modular suspension mechanism variations can includevariations in dimensions and aspects of shape or configuration, butinclude attachment features in common that attach to compatibleattachment features of the prosthetic socket. The suspension mechanismvariations in the inventory may be selected for structural features thatfit the person and are biomechanically appropriate for activities ordesired activities of the person.

Embodiments of the prosthetic socket may further include othercomponents or members, such as, and merely by way of examples, anischial weight-wearing member, a tendon-wearing member, a supracondylarextension member, a support or control extension member, a proximal brimmember adapted for ischial weight-wearing, or a proximal brim memberthat is specially designed for patellar tendon weight-bearing. Any ofthe members may have modular aspects, and may be drawn from an inventoryof such components, as has been described in the context of othermodular components provided herein.

Some embodiments of the prosthetic system, the prosthetic sock, or anyparticular component thereof may include sensors. Typically, suchsensors are in an operable relationship with either a microprocessorand/or responsive mechanical elements. Such sensors may include, merelyby way of example, an accelerometer, an inclinometer, or a gyroscope.These sensors and associated smart, operable, or responsive componentsmay be understood to provide adjustability to the prosthetic socket. Insome embodiments, the microprocessor is in communication with one ormore additional and separately located sensor or microprocessor, saidadditional and separately located sensor or microprocessor may bedisposed in any appropriate location within the prosthetic socket, or atanother location within a larger prosthetic device that also includesthe prosthetic socket.

As with adjustability as described elsewhere herein, adjustability isgenerally directed toward optimizing aspects of fit and flexibility, andaspects of biomechanical appropriateness for the individual. These formsof adjustment would generally be considered automatic by virtue ofmicroprocessors and responsive mechanisms, but they may also includemanually operable options.

In addition to the first embodiment of a modular prosthetic system, asreferenced above and then extensively detailed, the invention includesother particular embodiments. In the first embodiment, the prostheticsocket is one in which at least one of the three recited groups ofcomponents (struts, proximal brim members, and distal socket members)include components that are modular in nature. In the first embodiment,the prosthetic socket had dimensions and contours that substantially fitthe dimensions and contours of the residual limb.

In a first alternative embodiment of a modular prosthetic system, all ofthe three recited groups of components are modular. And the this firstalternative embodiment, the prosthetic socket, in addition to theprosthetic socket fitting the dimensions and contours of the residuallimb, the prosthetic socket is further configured to biomechanicallyappropriate for a range of activities in which the individual engagesin, or in which the individual desires to engage, or desires to continueto engage in.

In a second alternative embodiment of a modular prosthetic system, withreference to the three recited groups of components, all of the threerecited groups of components are modular, and at least one of thosethree groups of modular components includes components that areadjustable with respect to component dimensions of contours.

In a third alternative embodiment of a modular prosthetic system, withregard to the three recited groups of components, all three of therecited groups of components are modular, and the system furtherincludes an inventory of modular components for each of the three groupsof modular socket components. Modular components from each of the groupsselectable for assembly into a complete prosthetic socket.

A fourth alternative embodiment of the invention provides a kit ofcomponents from which a modular socket may be assembled. All of therecited groups of socket components are modular, and the components fromthe groups of socket components included in the kit are selected so asto be assemblable into a prosthetic socket that substantially fits thedimensions and contours of the residual limb and is biomechanicallyappropriate for activities of the individual.

Embodiments of the invention also include methods of making orassembling a prosthetic socket for a residual limb of an individualperson who has experienced the amputation of an extremity. Accordingly,one particular method embodiment is directed to making a modularprosthetic socket fitted to a residual limb of an individual person, theresidual limb having individual dimensions and anatomical contours.

This method embodiment includes providing inventories of one or moregroups of modular prosthetic socket components from which to assemblethe prosthetic socket, the components within each group having (1)variation in dimension or contour and (2) common connecting featuresthat permit assembly of the individual components together to form theprosthetic socket. This method embodiment further includes, withreference to the inventory of each component group, selecting one ormore components therefrom to assemble a residual limb socket that willsubstantially fit the individual dimensions and contours of the residuallimb when said components are later assembled into a residual socket.And the method further includes assembling the selected prostheticsocket components from each of the groups of components to form theprosthetic socket for the residual limb.

In this method embodiment, the groups of prosthetic components for whichinventories are provided include (a) struts to be arrangedlongitudinally with respect to the residual limb, each strut having adistal end and a proximal end, (b) proximal brim members to be arrangedproximally with respect to the one or more struts and connected directlyor indirectly thereto, and (c) distal socket members to be disposed atthe distal base of the prosthetic socket. In method embodiments whereinthe three groups of prosthetic group components are modular in nature,the method may further include selecting components from all threegroups and assembling them together to form the socket.

While these three particular groups of components are recited asexamples that are involved in the method, the scope of the methodincludes the use of other components, and any prosthetic socketcomponent, including any particular component or accessory elementassociated with the prosthetic socket that can be modular in the sensethat is described herein. And, particularly included within the scopefor use in the method is any prosthetic socket member, or component, orassociated apparatus that is described or depicted herein.

In some embodiments of the method, selecting a prosthetic socketcomponent is based on determining aspects of dimension and/or contoursof the distal portion of the residual limb, said determining stepincluding any one or more of scanning, photographing, casting, ormapping with a three-dimensional point reference device athree-dimensional digital or physical representation of the residuallimb.

In some embodiments of the method, selecting individual prostheticdevice components includes directly fitting the components to achievethe dimensions and anatomical contours of the assembled socket. In someembodiments of the method, selecting individual prosthetic devicecomponents may includes directly fitting the components to achieve a fitthat is biomechanically appropriate for activities of the person. A fitthat is biomechanically appropriate may include taking intoconsideration the height and weight of the person, and it may includetaking into consideration distribution of pressure by the prostheticsocket on the residual limb.

In some embodiments of the method, a component selected from aninventory of group components includes a composition that is moldable;in this case, method may further include molding the component directlyagainst at least a portion of the residual limb. Such molding istypically performed in order to improve the fit of the prosthetic socketwith regard to the dimensions or contours of the residual limb.

In some of the component embodiments, the moldable composition is labileto heat at a temperature that is sufficiently low so as to not injure aresidual limb when the limb is protected by a thermal barrier. In thiscase, the method may further include heating the moldable component,thermally protecting the residual limb with a flexible thermal barrier,and molding at least a portion of the component against the portion ofthe residual limb. In some of the component embodiments, the moldablecomposition is a curable composition. In this case, the method mayfurther include molding the component against at least a portion of theresidual limb, and then curing the component in its molded form.

In some embodiments of the method, prior to the assembling step, themethod includes providing an inventory of encircling members that areconfigured to be arranged orthogonal to the struts and connectedthereto, and then including the encircling members in the assemblingstep.

Some embodiments of the method further include adjusting any of thedimensions or contours of the prosthetic socket. In some of theseembodiments, adjusting any of the dimensions or contours of theprosthetic socket includes improving the fit of the socket to theresidual limb. In some embodiments of the method, adjusting any of thedimensions or contours of the prosthetic socket may further includeimproving a biomechanically appropriateness of the dimensions orcontours for activities of the individual.

In some embodiments of the method, the adjusting step is performed by aprofessional prosthetic fitting expert. In some embodiments, theadjusting step may be performed by the person wearing the socket. Insome embodiments, the adjusting step is performed automatically by amicroprocessor-associated mechanism.

In some embodiments of the method, adjusting any of the shape ordimensions of the residual limb socket frame may include adjusting avolume encompassed within a circumferential boundary defined by thestruts, a distal boundary according to the distal cup, and a proximalboundary according to the proximal ends of the struts.

In some embodiments of the method, adjusting may include redistributingpressure exerted by the prosthetic socket on regions of the residuallimb, such redistribution referring to when the person is wearing theprosthetic socket.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an example of a right above-knee(trans-femoral) prosthetic socket after the modular members have beenselected, assembled, formed, and adjusted to fit over an individual'sresidual limb.

FIG. 2 is a perspective view of an example of a right above-knee(trans-femoral) prosthetic socket after the modular members have beenselected, assembled, molded, but before it has been directly molded andadjusted to fit over an individual's residual limb.

FIG. 3 is a frontal cross sectional view of an exploded right above-knee(trans-femoral) prosthetic socket.

FIG. 4 is a frontal cross sectional view of the above-knee(trans-femoral) prosthetic socket shown exploded in FIG. 3 after it hasbeen assembled and including a total surface-bearing flexible innerliner after it has been assembled and formed to the individual'sresidual limb.

FIG. 5 is a top view of an example of a right above-knee (trans-femoral)prosthetic socket after the modular members have been selected,assembled, molded, but before it has been adjusted to fit over anindividual's residual limb. This perspective gives a clear view of anencircling tensioning member without microprocessor control.

FIG. 6 is a perspective view of an example of a below-knee(trans-tibial) prosthetic socket.

FIG. 7 is a perspective view of an example of an above-elbow(trans-humeral) prosthetic.

FIG. 8 is a perspective view of the same prosthetic sock as seen in FIG.7, after the proximal brim member 83 of FIG. 7 has been molded andtrimmed to produce the formed and trimmed proximal brim member 83 ofFIG. 8 in order to allow for increased range of motion.

FIG. 9 is a perspective view of an example of an above-knee(trans-femoral) modular prosthetic socket after it has been formed to anindividual's residual limb, this particular example having a cut-out inthe strut member that allows for an encircling band to sit flush.

FIG. 10 is a perspective view of an example of an above-knee(trans-femoral) modular prosthetic socket after it has been formed to anindividual's residual limb.

FIG. 11 is a perspective view of an example of a prosthetic socket ofthe present invention.

FIG. 12 is a perspective drawing of an example of a prosthetic socket ofthe present invention. This drawing is an example of a below-elbowsocket, otherwise known as transradial prosthetic socket.

FIG. 13 is a superior view of the distal cup of the Symes (an ankledisarticulation socket) modular prosthetic socket as also seen in sideview in FIG. 14.

FIG. 14 is a side view of a prosthetic Symes socket (ankledisarticulation socket), showing, in particular, a height adjustablemember with option for angular change.

FIG. 15 is a perspective view of an above-knee (trans-femoral) socketthat shows detail of a proximal brim with an adjustable section, as wellas an ischial seat extension.

FIG. 16 is a perspective view of the distal portion of an above-knee(trans-femoral) prosthetic socket, showing detail related to anintegrated suspension mechanism, and modular alignment feature and asettable hinge.

FIG. 17 shows lateral cross-section views of modular adjustable jointand hinge options, showing an option of utilizing wedges that may beremoved or replaced to change the desired angle.

FIG. 18 shows a hinge with setscrew, hinge cover, and strut wedge.

FIG. 19 is a superior perspective view of modular adjustable jointratchet options that may be utilized for the prosthetic socket.

FIG. 20 shows an adjustable hinge with the additional features ofretainer members as well as having the entire set beam member being aseparate member that may be placed separately and set into place.

FIG. 21 is a perspective view of an example of prosthetic socket havingan adjustable hinge member with microprocessor control.

FIG. 22 is a perspective view of an example of a portion of a prostheticsocket having an adjustable member with microprocessor control.

FIG. 23 is a perspective view of an example of a prosthetic sockethaving oval shaped struts 270 that extend past the socket and form acongruent pylon and foot system, representing an entire prosthesis.

FIG. 24 is the same illustration as FIG. 23, except that it shows theoption of having additional adjustment capabilities incorporated intothe struts 278 and the interface members 272, 276, and 288.

FIG. 25 depicts an embodiment similar to that in FIG. 23, except that itdemonstrates with an outline that there is the option of having theentire modular prosthesis covered with a cosmetic covering or fairing288.

FIG. 26 is a perspective view of a prefabricated wrap-around cosmeticcover 290.

FIG. 27 is a perspective view of oval shaped struts 294 and 300, Yconnecting joint member 298, proximal brim member 292, and proximal brimconnector 296.

FIG. 28 is a perspective drawing of an oval shaped strut member.

FIG. 29 is a perspective drawing of an oval shaped strut member 304 withcontour and transverse plane rotation 304.

FIG. 30 is a lateral perspective of an oval shaped strut member 304 withcontour and with adjustable interface member 310.

FIG. 31 is a flow chart showing an example of the steps involved inproviding a prosthetic limb for an individual by the method for fittinga custom modular prosthetic socket according to the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Overview

The applicability of molds to the process of creating sockets thataccommodate residual limbs and to provide a proximal base for effectiveprosthetic limbs and operable distal effectors is pervasive in the priorart, and has also been broadly helpful and therapeutically beneficial.As presented in the background, however, there are inherent andpractical limitations to this approach. Such limitations relate toresources, such as time and cost, and to actualities of fit to aresidual limb, wherein fit relates to a limb portion that is actuallynot well suited for bearing weight, providing a base of prosthetic limboperability. A residual limb comes with complications related to bodyheat and moisture that effect the interaction of the residual limb andthe socket. And, the residual limb, itself, is dynamic in shape andinternal structural details over time. These changes occur both in theshort term, as during the course of a day, and in the long term, as theindividual ages and deals with changes in body structure and activitiesof daily living.

A number of innovations disclosed herein address these briefly describedcomplicating aspects of providing a residual limb prosthetic socket tothat fits well, as a baseline, but is further dynamic in aspects of itsfit, and adjustable in aspects of its fit. As may be understood by thisdisclosure, these aspects of fit, dynamicity of fit, and adjustabilityof fit, at least in part, relate to the direct-fit manner in whichembodiments of the invention are made.

Embodiments of a method for making a prosthetic socket, as describedherein, may use a plurality of premade or custom-made members that aredesigned to function in a compatible way with one another, and areindividually selected and assembled in a customized and specific mannerto form a modular prosthetic socket to meet the needs of any amputee,whether for an upper or lower extremity.

Embodiments of residual limb sockets described herein may include adistal base member with specialized and contoured pressure distributionstruts. In one embodiment, by way of example, two flexible andadjustable members are positioned within each of the vertical and rigidstrut sections (vertical strut sections comprise the two flexiblesections and two rigid and specially contoured strut members made ofcarbon fiber and/or acrylic resin). An adjustable proximal brim with aratcheting patient-operated control may be used. The specializedcontours of the present prosthetic socket are configured to blockrotation, and to provide control and stability inside the socket withcomfort and without the need for total contact. This arrangementprovides the advantage of greater heat dissipation and anon-circumferential design that allows greater adjustability. Otherembodiments, however, may include a liner that provides total contactbetween the socket surfaces and the residual limb.

The present invention allows for various types of sockets and variousoptions for pressure profile distribution, as well as the modular andadjustable ability to change as the patient changes.

Embodiments of the basic method for making a prosthetic socket describedherein include a modular approach that uses a plurality ofpre-fabricated or custom-made members that are individually selected,oriented, and assembled in a customized and specific manner to meet theneeds of the amputee. The result of this modular prosthetic socketmethod is a custom modular member prosthetic socket. The custom modularmember prosthetic socket allows for one trained in the field to fit theprosthetic socket directly to the amputee's residual limb for an amputeeof either the upper or lower extremity, without the need to make anegative mold or a positive mold. The custom prosthetic socket canachieve optimal functioning results and comfortable fit by applyingpressure in pressure tolerant areas of the residual limb, whilesimultaneously relieving pressure in pressure sensitive areas of theresidual limb. A total surface-bearing interface may augment the modularsupport frame of the custom modular member prosthetic socket for thosewho require a circumferential or total surface-bearing prostheticsocket. Once fit to the amputee's residual limb, the modular system canserve as a complete, independent, and fully functioning prostheticsocket with its own interface options. Alternatively, it can be made towork with other related devices, including gel liners, suction systems,pin systems, vacuum systems, adjustable systems, and modular alignmentsystems.

Each member for the modular method is designed for compatible assembly.The modular method may include adjustability or conformability withinone or more of its members. This adjustability may come in the form ofbeing able to be trimmed to the proper size, heat molded, formed toshape, and then set. The adjustability includes telescoping heightadjustability, hydraulic controlled adjustability, pneumatic controlledadjustability, hinged controlled adjustability, slide controlledadjustability, foldable adjustability, and ratcheting adjustability. Themembers of the socket are thus expandable, or otherwise mobile,conformable, changeable, or adjustable. By selecting individual membersand adjustability of individual members, then orienting and assemblingselected members to match the needs and conditions of the amputee, themodular methods and resulting products described herein offer theadvantages of a custom made prosthetic socket with design modularity,while at the same time avoiding time consuming and wasteful mold makingtechniques as well as the disadvantages and limitations of premadesockets and alternative approaches of the prior art.

Embodiments and Features

The specific members, orientation, adjustability, materials, shape,contour, and relationship of embodiments of the modular prostheticsocket described herein are diverse in some aspects of their form, butnevertheless have features in common, particularly connection featuresas befitting of a modular overall design. Modularity is purposefullydirected toward providing versatility and adaptability. The design issuch that each member can be selected for its material composition,strength, durability, cost, shape, and size to match the needs of aparticular amputee. Further, the relationship between and among members,including their adjustability properties, locking abilities, controlmethod, fastening method, and orientation, may also be selected to matchthe needs of the patient. A pre-fabricated hinge and/or controlmechanism may be selected if an adjustable and locking relationship isdesired. Since the size, shape, and needs of all residual limbs areunique to each specific individual, each produced embodiment orrendering of the methods of making and using embodiments may be any ofindividualized, or custom-made, custom-assembled, or custom-adjusted.For the sake of describing the invention in detail, as a general module,as templates, as standard sizes or forms, as an inventory, as a kit, andas particular embodiments are described. In general, the modularprosthetic socket method described may include one or more of thefollowing types of pre-fabricated or custom-made members: a distalcontrol and attachment member, one or more adjustable members, one ormore structural struts or longitudinal links, height or lengthadjustable or extendable members, and/or width adjustable or extendablemembers, proximal brim and/or connecting link members, and additionalmembers.

The modular members, per embodiments of the invention, may be made in aseries of sizes and shapes of premade members that may be selected tofit a substantial portion of the residual limbs extant within thepopulation people with amputations. For cases where the shape, contour,or size of the amputee does not work well with premade members, custommolded members may be fabricated independently of or in conjunction withmembers that may be provided in a range of standardized sizes or form,as for example, could be included in an inventory of parts. The custommolded members may be made with pre-made members that are made with amoldable material, or they may be made with one of the techniques thatare already available in commerce.

Embodiments of the invention also are adjustable, such adjustabilityprovided, at least in part, by a modular approach to assembly.Adjustability and modularity lend themselves particularly well to trialfittings and trial periods of use, in order to arrive a final version ofa residual limb socket and related prosthetic components. Trial fittingsand trial periods of use also may be appropriate as needs of the patientchange, or as the physical from of the residual limb changes over time.

The distal member of the modular socket design, as provided hereinincludes attachment and adjustability mechanisms that are appropriateand compatible with modular alignment and component connecting members.This connection mechanism of the distal member serves as a connectorbetween the custom member modular socket and an adjustable ornon-adjustable pylon, modular alignment system, or other componentconnection like a knee, foot, or hand. The connection member is designedfor ease of use and compatibility with previously established modularalignment devices, as well as a wide array of alignment options to workproperly with the different alignment needs of different individuals.

Typical applications for embodiments of the modular method and deviceproduct include any of a definitive prosthetic socket, a temporaryprosthetic socket, an initial prosthetic socket, a post-operativeprosthetic socket, and a diagnostic prosthetic socket.

Customizability by Way of a Modular Assembly

Embodiments of the invention provide a modular prosthetic socket methodand resultant product where pre-fabricated or custom made modularmembers are selected and linked together to fit the needs, shape, andsize of any amputee's residual limb, for either the upper and lowerextremity. The modular and adjustable prosthetic system or parts thereinmay be used as any of a definitive prosthetic socket, temporaryprosthetic socket, initial prosthetic socket, post-operative prostheticsocket, diagnostic prosthetic socket, and/or as a casting aid for aprosthetic socket. The modular method and resultant product comprisesprefabricated or custom members, and may include any of the following:distal control and attachment member, one or more adjustable members,one or more structural struts or longitudinal links, height or lengthadjustable or extendable members and/or width adjustable or extendablemembers, proximal brim and/or connecting link members, and additionalmembers.

A variation in the fitting process of the modular design may includehaving a plurality of members that are preassembled for standard sizes,but allow for customized adjustment or swapping out of members toindividually fit a given amputee. Hence, standard or typical limb sizesand shapes may be pre-assembled or partially pre-assembled, and thensimply custom adjusted or modified to match the individual. An advantageof this approach is that less time is required to fit standard or commonresidual limb sizes and shapes. This alternative fitting method stillprovides the advantages of the modularity in design, in that it offerssuch benefits as augmentation and adjustability.

The embodiments of the methods, resulting products, and designsdescribed herein may be applied to other applications that are relatedto prosthetic devices, such as orthotics, robotics, crutches,exoskeletal applications, wheelchairs, mobility equipment, and otherapplications.

Embodiments and Features of a Distal Cup

The distal control and attachment member embodiments may be a custommade or a pre-fabricated contoured distal “cup”. The distal cup may varyfor different amputation levels and sizes of the residual limb, and maybe a fixed form or moldable or adjustable by heat modification or othermethod to reshape or accommodate for any high-pressure areas, sensitiveareas, or otherwise specific areas. This process of adjustability mayvary or differ per application. It may include use of materials such asheat relievable thermoset plastics and thermoplastics. The distal cupmay also be made of a moldable material such as carbon or fiberglassbraid with water-catalyzed resin, UV catalyzed resin, or other suitablematerial. Designs may vary, depending on the specific application,circumstance, and location of application. The variability of optionsfor materials, sizes, and methods is designed to meet the size,amputation level, and functional needs of any amputee.

This distal section serves as an attachment segment where various typesof components and additions may attach both proximally and distally. Forexample, there may be a compatible four hole attachment pattern andcenter bolt acceptor that can work with various and standardmanufactured knees, feet, and other terminal devices. The distal cup mayalso have an integrated distal end pad that is either custom made oroff-the-shelf, and/or suspension components such as a lanyard suspensionsystem, suction suspension system, pull-bag suspension system, pull n′tie suspension system, or other suitable system. The distal cup alsoserves to control the distal aspect of the amputated bone. This is a keyaspect to the design, in that an amputee must have adequate control ofthe prosthesis for successful use thereof. Moreover, distal control iscritical to biomechanical control and stability. The distal cup isdesigned to serve in providing this control by having multiple contouredshapes that can work to provide anatomical control for the variouslevels of amputation. For example, trans-femoral amputees commonly getexcess pressure and resultant pain at the distal lateral and distalposterior-lateral aspect of the prosthesis due to the biomechanicalforces in that area during gait. Therefore, the distal cup fortrans-femoral amputees is designed to have a contoured relief and moreproximal control crossbar options that will help to avoid these commonproblems. Another key aspect to the design is that the distal cup ismade to allow for attachment of the control struts at the appropriatelocation, angle, and height to allow for maximized control of boneyanatomy and accommodation of soft tissue.

For a push-on suction socket variation, various sizes of pre-made distalsuction cups made out of silicone, urethane, or other appropriatematerial can be fit to the patient, or if the patient does not fit wellin the off-the-shelf sizes, a custom silicone distal suction cup may befabricated. The selected material for the distal silicone cups mayinclude design details such as softer durometer distal portions toimprove comfort as well as adapting the contour to match the patient,and outside material distally to improve the ability to adhere to thedistal base member. This silicone cup may have integratedlocking/securing members that may then be locked into and adhered to thedistal base of the modular cup. For example, Velcro type tabs can beintegrated into the distal silicone cup, which can lock into the socket,or set screws, can be used as well as undercut tabs that allow thesilicone cup to lock into place in the socket. To ensure an optimal fitbetween the silicone distal suction cup and the distal base member,silicone adhesive, silicone replicator, or other material may be used toadhere the silicone distal suction cup to the distal base member whileat the same time filling in any voids or lack of total-contact. From thedistal base with integrated distal suction cup, any of the modularmember options may be selected as usual to match the patient's needs.This push-on suction socket style is especially applicable todisarticulation level amputees.

Embodiments and Features that Provide Adjustability

Embodiments of a prosthetic socket as provided herein may include one ormore adjustable member, mechanical joints, hinges, flexible sections,durometer changeable sections, replaceable fixed angle sections,microprocessor controlled joints, and/or other suitable adjustablesections that may be dynamically or statically adjusted to fit thepatient and meet his or her needs. This adjustable section is one waythat the present invention allows for volume adjustability or changes tothe amputee's residual limb. As presented, the mechanism ofadjustability may vary. There may be a specialized hinge or adjustablesection that may be automatically or manually adjusted to meet theamputee's needs. If automatically adjusted, the system may include theuse of pressure sensors and a microprocessor or microprocessors thatcontrol adjustment of the socket automatically to avoid excesspressures. The mechanism of automated adjustment may be a gearedmechanism, ladder ratcheting system, automated set pin, hydrauliccontrol, pneumatic control, or other suitable system. A mechanicallyadjustable section may also be utilized where a manual set screw, buttonlock, bail lock, drop lock, ratchet lock, or other suitable manual setoption may be utilized to set the angle of the adjustment or range ofadjustments. The mechanical adjustable member may be manufactured as aspecialty hinge, for example, that can easily be riveted to the distalcontrol member and strut members, and may include a mechanism thatallows for user or practitioner adjustability. The adjustable memberscan also be made to allow for installation into a lamination, and canalso be made to affix and function with various socket materials.

A durometer or rigidity changeable sections may be utilized as anadjustable section member that has the ability to automatically ormanually change in durometer at the desired time. For example, if thepatient wants to adjust the fit of their prosthetic socket, he or shecan pass a small electrical charge through their adjustable membersection by pressing a button that then allows the specialized materialto be flexible until at the adjusted position. Then it may be changedback to a stiff or set material. The adjustable member may also be a lowprofile and light option of a rigid plate that is selected for thecorrect angle, and may be wedged or changed out for a different anglefor adjustment. If the weight or activity level of the amputee is suchthat the adjustable component requires reinforcement, such reinforcementmay be added after the desired angle has been established by a rivetedreinforcement beam, fiberglass tape, or other suitable way to increasethe strength capabilities of the adjustable section. The manual orautomated system may include or be integrated into the strut and distalcup design described above. For example, if a ladder and automatedratchet is utilized, the ladder aspect of the strut may be designed toslot into the shaft or long axis of the strut for which it controls. Theadvantage of such an integrated design is to protect components andreduce bulkiness of the overall design. The proximal brim design canalso accommodate for the adjustability.

An addition to any of the embodiments described herein may be adjustableset screws, wedges, or other appropriate means to tighten and loosen thefit of the modular method socket onto the amputee's residual limb. Themeans of having such adjustability may vary in the ease ofadjustability, cost, durability, and other properties. These means maytherefore be selected or avoided altogether, based on the needs of theamputee, the environment, and cost constraints.

Embodiments that Provide Adjustability with Regard to Length

Embodiments of height or length adjustable or extendable members and/orwidth adjustable or extendable members may include of one or moreexpandable or adjustable members that may adjust or expand in heightand/or width and may be added to, fastened to, or integrated with thestrut section. The additions may be riveted in place, snapped on,manufactured as an integrated member within, or otherwise fastened in anappropriate way. This allows for increased variability to accommodatedifferent lengths and sizes of the residual limb, and may be used inconjunction with the other adjustability and accommodative methodsdescribed herein. This adjustable aspect of the design may also beomitted if not required for certain amputees or for more simplifiedversions of the design.

Embodiments of Linking Elements

Embodiments of structural struts or longitudinal links may includestructural weight bearing rigid or semi-rigid links or struts that maybe selected and adjusted to match the amputee's needs. These links maybe moldable or conformed for the patient by heat molding, resin curing,or other conformable options. The materials selected for these links mayvary for the appropriate location and use of the prosthetic socket. Forexample, for developing country applications, locally availablematerials and interfaces, such as aluminum, fiberglass, bamboo, andlocally available thermoset resins, may be selected.

Proximal Brim Embodiments

Embodiments of proximal brim members may include of one or more rigid,semi-rigid, and/or flexible members that attach to the struts. They maybe adjustable or fixed dynamically or statically. For example,connecting links may include a ratcheting section that is patientadjustable, a fixed and contoured rigid section, a rigid andnon-contoured section, and a flexible section. They may be designed toadd support or control and/or allow for the full range of motion for theparticular patient. They may also be utilized for suspension, such as asuper condylar proximal brim that suspends proximal to the condyles ofthe patient's skeletal anatomy. The proximal brim members of the modularand adjustable prosthetic system may be custom made for the individualor prefabricated. Prefabricated proximal brim sections are manufacturedin such a way that they are sized, contoured, and adjustable in such away that they can meet the needs of all or most amputees. This isaccomplished by utilizing specialized members with contours and sizesthat are appropriate for various sections of the socket and the variousamputation levels. Such proximal brim members may be manufactured withvarious methods and materials that may vary per application andlocation. The members are designed to have specific shapes that workwell to control movement of the prosthetic limb, while still beingcomfortable and allowing range of motion to facilitate the needs ofdifferent amputees. Such a proximal brim may also vary in itsapplication and design as well as associated connection members andmembers that allow for adjustability of the proximal brim membersdepending on the needs of the patient. For example, the same proximalbrim members may be selected for two different amputees, but the methodof attaching them to associated members and adjustment pieces may vary.The base or default design will have a standardized proximal brim shapethat is contoured to allow for muscle action and boney prominences thatare typical for each amputation level with overlapping and adjustablesegments that allow for adjustability that adapts to the patient'sresidual limb shape and size. An adjustable section may also involve astrapping or tying section and/or ladder and ratchet or other suitablesystem to allow for adjustability of the size of the brim design. Thebrim may include a moldable material that may be molded and remolded byheat, curable resin, or other suitable way to match the specific shapeneeds of the particular patient.

Additional Member Embodiments

Embodiments of a prosthetic socket, as provided herein, may includeadditional members such as, by way of example: ischial weight bearingseat extension members, tendon bearing extension members, supercondularextension members, support or control extension members, sensor members,levelometer members, accelerometer members, microprocessor members,automated or manual controlling members, padding or cushion members,lanyard suspension system members, pull-bag or pull-sock exit tubessuspension system members, pull-in sock or bag holding system for pullin and tie off suspension system members, suspension belt members,suction valve members, sealing sleeves or sealing system members,outside liner members, cosmetic and/or functional fairing members, sweatexpulsion valve members, self alignable distal attachment member, opencompatibility distal attachments, adjustable flexion-extension andadduction-abduction capable attachment components, total surface-bearingor increased surface-bearing members, additional strut or additionalcontrol cross-link members, and/or any other appropriate additions.Members such as these are elaborated on in greater detail below.

Ischial Weight Bearing Seat Extension Members

Embodiments of ischial weight bearing seat extension members areextensions to the struts and/or the proximal brim described above. Suchmembers are designed and shaped to allow for weight bearing oradditional support or control of the prosthesis by fitting under orapplying pressure to the inferior aspect and/or medial aspect of theischial tuberosity. This anatomical structure is a well-establishedweight bearing area, and is a pressure tolerant area for many amputees.Additionally, because of its connection with the spinal column, itserves as an effective means for stabilizing the prosthesis andcontrolling the prosthesis as the amputee moves his or her body. Sincethe anatomical shape and size of amputees varies, as well as theirpressure sensitivity and needs, the ischial weight bearing seatextension members may vary in pre-fabricated sizes and shapes.Additionally, such a member may be custom fabricated or beprefabricated, with part or the entire member formed from a moldableand/or adjustable material. The member may be used with the prostheticsystem described above for different amputation levels, but will be mostapplicable for trans-femoral amputees and hip-disarticulation amputees.The member may be attached and adjusted in any appropriate manner.Adjustment or function of the additional member may be automated ormanual.

Tendon Bearing Extension Members

Embodiments of tendon bearing extension members may include extensionsto the struts and/or the proximal brim described above. Such members aredesigned and shaped to allow for weight bearing or additional support orcontrol of the prosthesis by applying pressure to one or more tendons.For example, for trans-tibial amputees, the patellar tendon is wellestablished as a weight bearing or weight tolerant area. Therefore, thebearing extension members can be specifically configured and fit toapply pressure at the patellar tendon in order to distribute pressurefrom weight bearing at a pressure tolerant area. Since the anatomicalshape and size of amputees varies, as well as their pressure sensitivityand needs, the bearing extension members may vary in pre-fabricatedsizes and shapes. Additionally, this member may also be customfabricated or be prefabricated, with part or all of the member formedfrom a moldable and/or adjustable material. The member may be used withthe prosthetic system described above for different amputation levels,but will be most applicable for trans-tibial amputees. The member may beattached and adjusted in any appropriate manner. Adjustment or functionof the additional member may be automated or manual.

Supercondular Extension Members

Embodiments of supercondular extension members can be extensions to thedistal cup, struts, and/or the proximal brims described above. Suchmembers are designed and shaped to allow for suspension and/oradditional support or control of the prosthesis by applying pressure toone or more of the areas directly proximal to or above the condyles ofthe amputated bone, adjacent bone, or proximal bones. For example,trans-tibial amputees with short residual limbs or limbs with redundanttissue sometimes need additional medial-lateral control in order toadequately control the prosthesis. Therefore, the supercondularextension members can be specifically configured and fit to applypressure at the area directly proximal to or above the condyles of thefemur in order to distribute pressure from weight bearing at a pressuretolerant area. Since the anatomical shape and size of amputees varies,as well as their pressure sensitivity and needs, the supercondularextension members may vary in pre-fabricated sizes and shapes. Thismember may also be custom fabricated or prefabricated, with part or theentire member formed from a moldable and/or adjustable material. Themember may be used with the prosthetic system described herein fordifferent amputation levels, but will be most applicable fortrans-tibial amputees, Symes amputees, wrist-disarticulation amputees,and trans-radial amputees. In some cases, it may be necessary to have anadditional members associated with the supercondular extension membersto allow for the supercondular section to be adjustable and/orremovable. Adjustability can provide the advantage of being able to varyhow much support or control is used, and/or removability of thesupercondular extension members can be required for donning and doffing.The member may be attached and adjusted in any appropriate manner.Adjustment or function of such an additional member may be automated ormanual.

Support or Control Extension Members

Embodiments of support or control extension members may include any oneor multiple extensions to any other members or part therein. The membersare designed and shaped to provide or aid in suspension and/oradditional support or control of the prosthesis. Such a member may beattached and adjusted in any appropriate manner. Adjustment or functionof such an additional member may be automated or manual. Since theanatomical shape and size of amputees varies, as well as their pressuresensitivity and needs, support and control members may vary inpre-fabricated sizes and shapes. Additionally, this member may also becustom fabricated or be prefabricated, with part the member or theentirety of the member being formed of a moldable and/or adjustablematerial. The member may be used with the prosthetic system describedherein.

Sensor Members

Embodiments of sensor members may include an additional member of themodular and adjustable prosthetic system that allows for some form ofdetermination or calculation of the amount of force, torque, load,and/or pressure being applied at one or more members and/or parts and/orportions of members. The force sensor member can sense, determine, orcalculate the amount of force, torque, load, and/or pressure in manydifferent ways, including, by way of example, in-line load cells,pancake load cells, rotary shaft torque sensors, and flush threadedpressure sensors. Data that is collected from the sensors may be relayedto a remote or onboard microprocessor unit for immediate or future use,and/or stored or saved remotely or onboard the modular and adjustablesystem. The member may be attached and adjusted in any appropriatemanner. Adjustment or function of such an additional member may beautomated or manual.

Inclinometer Members

Embodiments of inclinometer members may be integrated with or added tothe modular and adjustable prosthetic system. Such a member may beattached and adjusted in any appropriate manner. Adjustment or functionof the additional member may be automated or manual. Measurements ofangles with respect to gravity for the prosthetic system can be used tohelp avoid a fall for the amputee, or help with the ability to navigatestairs, ramps, hills, or other obstacles. These measurements may berelayed to a microprocessor unit that may be integrated into theprosthetic system, attached, and/or remote.

An inclinometer or clinometer is an instrument for measuring angles ofslope (or tilt), elevation or depression of an object with respect togravity. It is also known as a tilt meter, tilt indicator, slope alert,slope gauge, gradient meter, gradiometer, level gauge, level meter,declinometer, and pitch and roll indicator. Clinometers measure bothinclines (positive slopes, as seen by an observer looking upwards) anddeclines (negative slopes, as seen by an observer looking downward).

Accelerometer Members

Embodiments of accelerometer members may be integrated with or added tothe modular and adjustable prosthetic system. Such a member may beattached and adjusted in any appropriate manner. Adjustment or functionof the additional member may be automated or manual. Measurements ofacceleration for the prosthetic system can be used to help avoid a fallor accident for the amputee, or help with the ability to navigatestairs, ramps, hills, or other obstacles. These measurements may berelayed to a microprocessor unit that may be integrated into theprosthetic system, attached, and/or remote.

An accelerometer is a device that measures the proper acceleration ofthe device. This is not necessarily the same as the coordinateacceleration (change of velocity of the device in space), but is ratherthe type of acceleration associated with the phenomenon of weightexperienced by a test mass that resides in the frame of reference of theaccelerometer device.

Gyroscopic Members

Embodiments of gyroscope members may be integrated with or added to themodular and adjustable prosthetic system described herein. Such a membermay be attached and adjusted in any appropriate manner. Adjustment orfunction of the additional member may be automated or manual.Measurements or maintaining orientation for the prosthetic system may beused to help avoid a fall or accident for the amputee, or help with theability to navigate stairs, ramps, hills, or other obstacles. Thesemeasurements may be relayed to a microprocessor unit that may beintegrated into the prosthetic system, attached, and/or remote.

A gyroscope is a device for measuring or maintaining orientation, basedon the principles of conservation of angular momentum. In essence, amechanical gyroscope is a spinning wheel or disk whose axle is free totake any orientation. This orientation changes much less in response toa given external torque than it would without the large angular momentumassociated with the gyroscope's high rate of spin. Since external torqueis minimized by mounting the device in gimbals, its orientation remainsnearly fixed, regardless of any motion of the platform on which it ismounted.

Gyroscopes based on other operating principles may also be used, such asthe electronic, microchip-packaged MEMS gyroscope devices found inconsumer electronic devices, solid-state ring lasers, fiber opticgyroscopes, and extremely sensitive quantum gyroscopes.

Weight-Bearing Surfaces

A total surface bearing interface may augment the modular support frameof the modular member socket for those who require a circumferential ortotal surface-bearing prosthetic socket. The interface may also beutilized to increase the weight-bearing areas, but not necessarilyprovide total surface-bearing. This interface may vary in its materialand application, but may include a light but strong nylon or compositematerial similar to those found in backpacks. It may be a curablematerial that may be set to a given shape, may be made from a lowtemperature material that may be molded directly over the residual limb,or may be made in any other suitable way. The material of the interfacemay be flexible or rigid, and may span part of the socket or the entiresocket area. These interfaces may be fit within the modular socket, orthey may be formed or ordered separately and then inserted. The meansfor integrating such an interface with the modular socket may vary, butmay include an integrated or separately attached snap, Velcro, orratchet system to lock it into place in the structural modular frame.

Flexible Inner Liners

Other versions of the invention may utilize flexible inner liners orflexible inner brims. These members may or may not be totalsurface-bearing, as described above, but may be made in a similar way aslisted for the interface. A flexible brim may be fabricated separatelyafter establishing the frame, or integrated, and provides added comfortat the brim of the prosthesis without needing to cover the entireresidual limb. This allows for increased comfort without addingunnecessary weight to the prosthesis.

Combined Use of Pre-Fabricated and Custom Fabricated Frame Members

The embodiments of the methods, resulting products, and designsdescribed herein can be utilized as a hybrid of custom-fabricated andpre-fabricated members. Additionally, aspects of this modular method andsystem may be utilized to augment, add, or be compatible withtraditional or common methods of fabricating a prosthesis. For example,a prosthetist may choose to fabricate using traditional means, but maywant to incorporate an adjustable member from the modular method andsystem. Certain modular method members can be designed to work likethis.

Typical embodiments described herein are custom made, custom assembled,and/or custom adjusted for optimal results, however, some embodimentsinclude pre-made and preassembled version of the design could be idealand self-contained without the need for alteration by a trainedprofessional. This could be true for individual instances, or therecould be an alternative embodiment of the general module that is useradjustable and otherwise prepared for application and use by theamputee. The alternative embodiments may utilize one or more aspects ofthe embodiments described herein.

Connecting and Adjusting Mechanisms

One or more of the parts, methods, members, or aspects within theoverall invention described here may be utilized independently withother designs or methods. For example, one of the hinges, fasteningmechanisms, ratcheting systems, adjustable systems, or automated controlsystems specially designed for this modular method of prosthetic socketsmay be sold separately for integrated use with traditional fabricatingmethods.

Use of Low Durometer Silicone

Additional material, such as low durometer silicone, may be added to theinside of the modular members to provide a surface that will help tomaintain suspension of the residual limb inside the socket and avoidpistoning of the residual limb

Frame Member Features

The modular method may include one or more oval shaped structural strutsthat are different than previously discussed in that they are shapedsuch that their cross section looks like an oval or an almond withrounded ends. Advantages to this type of strut include that it could bestrong yet light, that its rounded edges and dual convex outer surfaceshape provide an ideal pressure distribution and safe edge surface, thebulkiness is limited, and it has great ability for adjustability andcompatibility. The almond shaped structural strut alternative may besolid or hollow, may vary in flexibility, material, adjustability(adjustability may come from material capabilities and/or mechanicaldesign capabilities), size, and exact shape.

A standard or set of standards can be chosen and maintained asconsistent in order to be compatible with accompanying members. Forexample, the almond shaped structural members may have a 1″ widthversion and a 1.5″ width version and be fabricated to work withcompatible angular change members, hinges, adjustable hinges, joiningmembers, crossbeam members, adjustable extensions, proximal brimconnection members, distal member connection members, sensors, etc. Forexample, one almond shape structural strut member may be anchored to adistal base member with an adjustable hinge, then it may apply amedially directed force onto the patient's residual limb through themiddle part of the residual limb. It may be joined with a [Upsilon]'type joining member that connects it with two other almond shapestructural strut members who divert pressure away from the amputee'sfibula head, and then join with the proximal brim member. The almondshape structural strut members may include pressure distribution padsthat are adjustable with use of wedges, set screws, or other adjustablemeans.

The adjustability and compatibility of the almond shape structural strutmembers may include any one or more of the following: mechanical angularchange capabilities (such as accordion type angular changes, tiltangular changes, bowing angular changes, twisting angular changes,etc.), conformability of material capabilities, and use of compatibleconnection members. For this embodiment or for any of the otherembodiments described herein, one or more of the members involved in themodular method socket may also be utilized as a functional or aestheticextension from the socket. For example, the type of oval or almondshaped strut system in this embodiment may also be utilized to extendpast the distal socket member and thereby serve as a modular pylonsystem as well. Such a system may also become the foot or part of thedistal components and terminal device. The advantage of such a system isthat the whole prosthetic system then works as a comprehensive system,thereby improving energy transfer and efficiency. This embodimentexemplifies that these modular methods and members may be extended tothe use of the entire prosthetic limb. Having a congruent system thatworks directly with the modular members of the modular method systemprovides an advantage over the current alignment components, joints, andterminal devices that are available. What is more, the almond shapestructural strut members may be used for other significant applicationssuch as, by way of example, orthotics, robotics, and human exoskeletonsystems.

Dynamic Tightening or Compression

The modular method may include a dynamic tightening or compression fromthe struts. For example, spring loaded hinge members or other means ofdynamic compression may be used to connect to strut members to provide adesired amount of compression on the amputee's residual limb. This canbe desirable in that it can improve suspension and control of theprosthesis. This embodiment can also function similarly to a Chinesefinger trap, in that the further the amputee's residual limb is pusheddown into the modular socket, the more resulting suspension and snug fitthe amputee receives.

Specialized Hinges and Adjustable Members

The modular method may include one or more specialized hinges oradjustable members that are specifically designed and selected to workwith elevated vacuum socket systems utilized in prosthetics. Forexample, the modular hinges may be selected as being low-profile andfree-motion so that the compression and fit that is established from theelevated vacuum system can be what determines the relative position andcontours of the socket. In this example, the modular socket may be wideror narrower as needed, depending on the current size of the amputee'sresidual limb, while the elevated vacuum provides the appropriate amountof compression, control, and suspension. This is an advantage over theprior art in that the socket will more easily change with the amputee ifthe size or shape of their residual limb changes.

Microprocessor Members for Adjustability, Adaptability, and Operability

Embodiments of microprocessor members may include an additional memberof the modular and adjustable prosthetic system that allows for someform of determination or calculation of the amount of force or pressurebeing applied at one or members and/or parts and/or portions of members.The force sensor member may sense, determine, or calculate the amount offorce or pressure in a variety of ways. The member may be attached andadjusted in any appropriate or effective manner, either manually orautomatically.

The microprocessor unit can be programmed to use these measurements tomake appropriate changes in the socket for specific activities, aid incontrolling components distal to the prosthetic socket (such as a knee,foot, or elbow), or relay and collaborate with other sensors and controlmechanisms distal to the socket. These are advantageous capabilities forprosthetic limbs, because they allow for orientation, angle, andpositional information and adjustability options within, and at thelevel of, the prosthetics socket. The capability or capabilities ofusing one or more of the member options described above may be combinedwith microprocessor and sensor capabilities at the distal componentry toprovide a new level of artificial limb awareness and ability. Theadvantage of the system having orientation, angle, and positionalinformation and adjustability options is beneficially analogous tonormal human locomotion, which also uses neural sensors and the centralnervous system to process this information in order to know how to moveand react to the surroundings properly.

The modular method may include one or more microprocessor controloptions that are designed and programmed to communicate and worktogether or in conjunction with other components of the prosthesis. Forexample, microprocessors utilized to adjust the fit and function in thesocket may communicate with the prosthetic knee and/or prosthetic foot.Fit can be customized are adaptable as may be appropriate for a specificactivity, environment, or position of the prosthesis. For example, anamputee may need his or her socket to fit more snugly when they arerunning in order for the socket to be more safe and secure, or thesocket may automatically loosen at the posterior when the amputee issitting, for increased comfort.

Embodiments of automated or manual controlling members may include anadditional member of the modular and adjustable prosthetic system thatprovides means for controlling, moving, limiting, or guiding one or moremembers and/or parts and/or portions of members. For example, theautomated controlling members may be a motorized hinge system thatautomatically controls the angle of the strut member in relation to thedistal cup by a motorized ladder and ratchet system controlled by themicroprocessor. Alternatively, the manual controlling members may be ahand driven ratchet and ladder system or an adjustable hinge mechanism.The automated or manual controlling members may be integrated into oneor more of the other members described herein. The member may beattached and adjusted in any appropriate manner.

Microprocessor control may be utilized to control the adjustability ormovement of one or more of the members involved in the modular membersocket. For example, one or more automated control hinges may becontrolled by a microprocessor. This microprocessor may collect datafrom sensors inside the socket and/or outside the socket, and have anoption of communicating with other microprocessors such asmicroprocessor-controlled knees and feet. These data may then be used toadjust the socket fit to be appropriate for the needs of the patient.For example, if the patient starts running, the socket may tighten toincrease control and suspension, or if the patient is sitting, thesocket can loosen for increased sitting comfort.

Microprocessor control and other aspects of the modular system may beincorporated into other parts of the prosthesis and other systems beyondthe socket per se. For example, the microprocessor that helps to controlmovements or adjustments in the socket may communicate with andcooperate with other parts of the prosthesis, such as the knee and foot.The modular socket design may incorporate an adjustable tension cablethat is integrated with and adjusted at the level of the modularalignment pylon. Additionally, the connection member may be assembledwith modular alignment members that are made specifically to add to orassist in the functioning of the modular socket system.

Use of a Dynamic Jig in Fabrication of a Residual Limb Socket

The embodiments of the methods, resulting products, and designsdescribed herein may also be utilized as dynamic jig methods for settingprocesses of a direct fit system and/or as a casting aid for aprosthetic socket. For example, the same or similar modular membersdescribed herein to make a finished socket may also be used as a way toform a weight-bearing cast or mold of the residual limb or a direct fitsocket. This may be especially useful when a total surface-bearingsocket is required or preferred. The direct fit socket may be made of acarbon, fiberglass, Kevlar, or composite material with pre-impregnatedresin that may be catalyzed at the desired time with UV, water, or othersuitable means. Other novel and specialty aspects to this direct fitmaterial and method may be incorporated, such as a trimmable andTollable edge, the ability to heat relieve and adjust the socket, theability to have built-in modular and adjustable options, and the abilityto have selected rigidity in selected areas. This system is advantageousover prior art in that it allows for static and dynamic testing for thecomfort of the socket before the socket is hardened. Therefore, apatient can try the socket fit with the direct fit material in place andthe modular members supporting and controlling the fit of the direct fitmaterial in the appropriate locations, and then the socket may beadjusted using the modular method adjustability if the patient isexperiencing discomfort anywhere. Then at the desired time, the directfit socket may be catalyzed. The advantage that this method has overjust sticking with the modular supporting frame is that it may allow forthe socket to be lighter and less bulky without the supporting andadjustable features. Alternatively, a middle ground can be utilizedwhere part of the modular frame is used, or part of the adjustability ofthe modular system is used and part of the direct fit sleek and lightframe is used.

Residual Limb Measurement Approaches

The modular method may include a step of scanning, photographing,casting, three-dimensional point reference system, or other means ofobtaining a three-dimensional digital or physical representation of theresidual limb. A physical or digital positive representation of theamputee's residual limb may then be utilized to fabricate one or morecustom contoured members, such members including, for example, customfabricated struts, connecting members, adjustable members, distal basemembers, proximal brim members, or any other member. These custommembers may be manufactured using direct manufacturing,three-dimensional printers, lamination, injection molding, or othersuitable or preferred manufacturing or fabricating methods. In any case,the end product is a custom modular prosthetic socket that is then fitdirectly to the patient.

This alternative embodiment of the present invention offers the optionof custom making the members based on that positive representation andother patient evaluation information, such as weight and activity level,with the expense of adding complexity, time, and cost to the process ofcreating the modular method socket. This alternative embodiment may beideal for certain cases where custom fit and custom adjusted premademembers will not serve the needs of the patient. It may also be chosenwhen the increased complexity, time, and cost are not an issue.

This alternative embodiment of a custom modular prosthetic socket stillhas advantages over the prior art in that it reduces the complexity offabrication, because the same manufacturing techniques, machines, andmaterials used for the premade members may be used to fabricate thecustom made members. They may be fabricated as individual members, thenassembled and adjusted to meet the patient's needs. The alternativeembodiment still offers the advantages that come with modular methods,as well as increased adjustability by both the practitioner and thepatient. The modular methods make it easier to get a good fit of theprosthetic socket because of the inherent adjustability and modularityof the socket after fabrication takes place.

Covers and Fairings

Embodiments of a modular method socket, as provided herein, may includea cosmetic cover or aesthetic fairing. This cosmetic cover or aestheticfairing may be made to connect to and be compatible with the rest of themodular method socket. This cosmetic cover or aesthetic fairing may becomplex and expensive when made with state of the art materials, orrelatively simple and inexpensive when made with low-cost materials. Forexample, prefabricated wrap-around cosmetic covers that are in the shapeof a calf may be made of color appropriate low-density polyethylene toproduce a low cost, water resistant, and durable solution.

Incorporation of Advanced Materials and Available Materials

The embodiments of the methods, resulting products, and designsdescribed herein may be manufactured with advanced materials andmanufacturing techniques and/or precision machinery, including 3Dprinting technology.

Other versions may utilize desired combinations of newly invented andpreviously introduced materials, manufacturing capabilities, joints,hinges, user adjustability, microprocessor control, automated or manualadjustment control, adjustable options, and other emerging technologies.Being able to utilize these emerging technologies and specialized partsthat can be manufactured in a selected and interchangeable way, thenincorporated into the basic modular prosthetic socket method, is one ofthe benefits of this method and an advantage over the prior art. Thismodular system can more easily incorporate new technology.

The embodiments of the methods, resulting products, and designsdescribed herein may be manufactured with basic materials andmanufacturing techniques that can be made in affordable and locallysustainable ways. This can be ideal for developing world applications.Alternative forms of the invention include using low-cost, sustainable,and locally available materials (such as bamboo) for developing countryapplications. This can be especially beneficial for the tens ofthousands of amputees who go without prostheses in developing countries.Other aspects to the present invention, like easier training, fasterdeployment, less space, fewer tools, and the like, make the presentinvention applicable to developing countries and relief situations. Thedesired method of distribution can be something like what is done withthe Tom's Shoes system, where for each modular method prosthesis orprosthetic socket that is purchased in a developed country; someone whocannot afford a limb gets fit with one in a developing country.

Particular Advantages of Embodiments of the Invention

The following aspects of the invention, as provided herein, may beunderstood as being advantageous, with particular reference toconventional fabrication processes that are reliant on molding steps oron direct fit limb socket approaches that have been attempted to thispoint.

1. Method embodiments of the invention, as described herein, are highlyefficient in terms of required time and resources. These aspects of theinvention favor it economically, within any economy, but the relevanceis increased in environments where resources are limited.

2. Embodiments of the invention little space and little machinery todeliver custom-fitted sockets. These advantages have particularrelevance in emergency relief situations where infrastructure has yet tobe reestablished following a natural or man-made disaster.

3. Embodiments of the invention provide adjustability features thatextend beyond the capabilities associated with a bivalve arrangement,telescoping features, or circumferential wrapping design. In particular,the adjustability of the socket may be assembled for a changing pressureprofile that matches the patient's changing needs over time.

4. Embodiments of the invention provide the capability for the residuallimb socket to adjust for volume fluctuation in the residual limb, andare highly adaptable for different limb sizes and shapes. This is due tothe fact that the individual members are selected and assembled to meetthe needs of the individual amputee. Hence, the angles and contours ofthe selected members may be oriented and assembled to meet the needs ofvirtually any amputee.

5. Embodiments of the invention require relatively brief training forsuccessful delivery and follow-up. The method also has a relatively lowlevel of complexity for what the trained healthcare professionals arerequired to do in order to fabricate and fit the amputee.

6. Embodiments of the invention advantageously provide for enhancedability to dissipate heat and perspired and environmental moisture.

7. Embodiments of the invention are highly adaptable or compatible toany given or conventional mechanism by which suspension of theprosthetic is achieved.

8. Embodiments of the invention, as methods for making a residual limbsocket do not necessarily require electrical power to implement.

9. Embodiments of the invention are advantageously able to use desiredcombinations of conventional and new materials, joints, hinges, useradjustability, the microprocessor control, automated or manualadjustment control, and adjustable options. The specialized parts may bemanufactured in a selected and interchangeable way that is easier tomanufacture than current designs.

10. Embodiments of the invention allow for user empowerment and controlregarding adjustability, repair, and other user controllability over theoperability of their prosthetic socket and complete assembly, as may beappropriate.

11. Embodiments of the invention provide a quick route to get theproduct to a point of a trial fitting on the amputee, and to makechanges as may by appropriate per the trial fitting.

12. Embodiments of the invention have a modular assembly aspect thatallow it to adapt and work well with emerging surgical, biological, andtechnical advancements, as represented, for example, by implants andosseointegrated devices.

13. Embodiments of the invention, by virtue of having a shortmanufacturing time, release available time for training, therapy, andinstructions on care, use, and follow-up. Allowing more time to addressthese goals positively affects patient outcomes.

14. Embodiments of the invention allow for various types of socketshapes and various options for pressure profile distribution, as well asthe modular and adjustable ability to change as the patient changes.

15. Embodiments of the invention may utilize CAD/CAM technology,scanning and imagery technologies, and other shape capturing technology,as well as 3D printing and other manufacturing technology.

16. Embodiments of the invention, in the absence of mold-related stepsand in view of minimal fabrication time, offer the ability to test theprosthesis under its intended weight-bearing conditions.

Illustrated Embodiments

FIG. 1 is a perspective view of an example of a right above-knee(trans-femoral) prosthetic socket after the modular members have beenselected, assembled, formed, and adjusted to fit over an individual'sresidual limb. Item 1 of FIG. 1 is an example of a proximal brim memberspecially fabricated and engineered for the anterior-medial aspect ofthe proximal brim for an above-knee (trans-femoral) modular prostheticsocket after it has been formed directly to match the individual'sresidual limb. Item 2 is an example of a proximal brim member speciallyfabricated and engineered for the ischial aspect of the proximal brimafter it has been formed directly to match the individual's residuallimb wherein it is engineered and fabricate to be able to form forsocket ischial containment. Item 3 is an example an encircling bandafter it has been formed directly to match the individual's residuallimb. This particular example is a semi-rigid and formable maletelescoping member of an encircling band after it has been formed to theindividual's residual limb. This particular example of an encirclingband is an encircling band that is engineered to be able to manuallytighten or loosen as enabled by the rotary tensioning mechanism 12 andinternal tensioning cables that run through the inside of the encirclingband 3. Item 4 is an example of a semi-rigid and formable femaletelescoping section of the encircling band after it has been formeddirectly to the individual's residual limb. Item 5 is an example of theinner surface of a strut after it has been formed directly to theindividual's residual limb. This inner surface has an appropriatematerial to match the individual's needs such as a silicone pad forsuspension and shock absorption as well as lateral moisture wickingmaterials. Item 6 is an example of a second encircling band after it hasbeen formed directly to match the individual's residual limb. A secondencircling band has been added in this example as a way to increasesocket strength and strength of adjustability for a high activityindividual. Item 7 is an example of a strut after it has been formeddirectly to contour to the individual's residual limb. Item 8 is anexample of a distal cup member after it has been formed directly to fitthe individual's residual limb. Item 9 is an example of a set screw forstrut telescoping mechanism 10 used to set the desired height of thestrut wherein the height of the strut can be adjusted to match the needsof the individual person's residual limb. Item 13 is two examples of aproximal brim member specially fabricated and engineered for the lateralaspect of the proximal brim for an above-knee (trans-femoral) modularprosthetic socket after they have been formed directly to match theindividual's residual limb. Item 21 is an example of a distal attachmentmember, to which distal ends of the struts 7 are attached, and which isdescribed in more detail in reference to FIGS. 2 and 3.

FIG. 2 is a perspective view of an example of a right above-knee(trans-femoral) prosthetic socket after the modular members have beenselected, assembled, molded, but before it has been directly molded andadjusted to fit over an individual's residual limb. Item 14 of FIG. 2shows two examples of a proximal brim member specially fabricated andengineered for the lateral aspect of the proximal brim for an above-knee(trans-femoral) modular prosthetic socket before they have been formeddirectly to match the individual's residual limb. Item 15 is an exampleof a proximal brim member specially fabricated and engineered for theischial aspect of the proximal brim for an above-knee (trans-femoral)modular prosthetic socket before it has been formed directly to matchthe individual's residual limb. Item 22 is an example an encircling bandbefore it has been formed directly to match the individual's residuallimb. This particular section is an example a semi-rigid and formablefemale telescoping member of an encircling band before it has beenformed to the individual's residual limb. This example of an encirclingband is an encircling band that is engineered to be able to manuallytighten or loosen as enabled by the rotary tensioning mechanism, 12 andinternal tensioning cables that run through the formable male, 23 andfemale, 22 telescoping members and connect to the tensioning mechanism.Item 18 is an example of a strut in its prefabricated form before it hasbeen formed directly to match the individual's residual limb. Item 19 isan example of a distal cup in its prefabricated form before it has beenformed directly to match the individual's residual limb. Item 20 is anexample of distal portion of a strut wherein this particular strut typehas a metal base which connects at an assembled distal attachment member21 This particular type of distal portion of a strut 20 is designed tobe adjustable in the angle by which it is mounted to the distalattachment member 21 as well as being directly formable to theindividual. The compatible and adjustable relationship between thisdistal portion of the strut 20 and the assembled distal attachmentmember 21, is also an example of how the overall modular prostheticsocket is engineered such that the separate specialized members that canbe selected from an inventory of specialized members to custom match theend user's needs are engineered to be compatible and/or adjustable toone another wherever appropriate. Item 24 is an example of an insidesurface of a strut before it has been formed directly to match thecontours of an individual's residual limb and/or cut to an appropriatelength for the individual's residual limb. This inside surface of astrut member 24 includes a shock absorbing material such as silicone aswell as including lateral wicking moisture channels. Like other strutsurfaces, these surface materials are engineered for ease of replacementin order to provide simple methods to be able to add materials orcomponents that offer specific properties or attributes that arebeneficial for the end user. Item 25 is an example of a proximal brimmember specially fabricated and engineered for the anterior-lateralaspect of the proximal brim for an above-knee (trans-femoral) modularprosthetic socket before it has been formed directly to match theindividual's residual limb.

FIG. 3 is a frontal cross sectional view of an exploded right above-knee(trans-femoral) prosthetic socket. This embodiment provides encirclingtensioning member with microprocessor control, outside t-nuts to enableencircling wrap of fiberglass casting tape or similar means to increasepressure distribution area in a directly formable and low-cost way aswell as provide a location to attach a cosmetic cover. Item 15 of FIG. 3is an example of a proximal brim member specially fabricated andengineered for the ischial aspect of the proximal brim for an above-knee(trans-femoral) modular prosthetic socket before it has been assembledand before it has been formed directly to match the individual'sresidual limb. Item 27 is an example of an insertion member of proximalbrim member 15 wherein the insertion member is fabricated and engineeredto be compatible with the insertion member of a proximal brim receiver28 of the strut 18. The specific mechanism of mounting a proximal brimmember to the proximal aspect of a strut may vary but this exampledemonstrates that the proximal brim members are fabricated andengineered to be able to mount to the proximal aspect of a strut. Item22 is an example an encircling band before it has been formed directlyto match the individual's residual limb. This particular section is anexample a semi-rigid and formable female telescoping member of anencircling band before it has been formed to the individual's residuallimb. This example of an encircling band is an encircling band that isengineered to be able to manually tighten or loosen as enabled by thetensioning mechanism 12 and internal tensioning cables that run throughthe formable male 23 and female 22 telescoping members and connect tothe tensioning mechanism. Item 29 is an example of a t-nut which ismounted to the outside of strut 18 as a means to allow ease inattachment of a cosmetic cover, tensioning system, encircling ring,and/or to allow for the struts to be structurally reinforced as well asincreased in their surface area by an external surface-bearing interfacewrapping circumferentially around the external surface of the strutswith a direct formable fiberglass casting tape or other applicable meansfor providing an increased weight bearing surface area or totalsurface-bearing addition to the struts in a way where thecircumferential wrap can be easily fixed to the struts by grinding thecasting tape down to the top of the t-nut after the casting tape hashardened and then screwing rounded bolts into the t-nuts, or foraffixing other beneficial members. Item 20 is an example of distalportion of a strut wherein this particular strut type has a metal basewhich connects at an assembled distal attachment member 21. Thisparticular type of distal portion of a strut 20 is designed to beadjustable in the angle by which it is mounted to the distal attachmentmember 21 as well as being directly formable to the individual. Item 30is an example of the distal component of the resulting assembled distalattachment member 21 wherein this distal component of the resultingassembled distal attachment member 21 is fabricated and engineered suchthat it has a serrated channel 31 to accommodate being joined togetherwith the serrated channel 31 of a proximal component 37 of the resultingassembled distal attachment member 21 in order to receive and attach thedistal aspect of a strut 20 in the desired location and angle, as wellas drilled holes to accommodate standard endoskeletal alignmentcomponents and moisture evacuation channel/s and/or suspension channel33. Item 32 is an example of a distal attachment bolt which is used tojoin a modular alignment mechanism together with proximal and distalcomponents of the resulting assembled distal attachment member 21. Item33 is an example of a moisture evacuation channel/s and/or suspensionchannel which is incorporated into the assembled distal attachmentmember 21, distal cup, end pad, flexible inner liner and/or other distalmembers in order to allow the modular prosthetic socket to be compatiblewith existing methods of suspension such as shuttle locks and moisturemanagement as well as allow for proprietary members for means ofsuspension and moisture management that the inventors are currentlyworking on such as specialized locking mechanisms with air seal, one-wayvalve/s, and specialized moisture channels. Item 34 is an example of anattachment bolt which is used to join a distal cup together with anassembled distal attachment member 21. Item 35 is an example of amodular alignment component that is compatible with commonly usedendoskeletal prosthetic alignment systems. Item 37 is an example of theproximal component of the resulting assembled distal attachment member21 wherein this proximal component of the resulting assembled distalattachment member 21 is fabricated and engineered in order to receiveand attach the distal aspect of a strut 20 in the desired location andangle, as well as drilled and tapped holes to accommodate standardendoskeletal alignment components, distal cup, and moisture evacuationchannel/s and/or suspension channel 33. Item 38 is an example of aprefabricated direct formable distal end pad with a moisture evacuationchannel/s and/or suspension channel 33 before it has been formed to thedistal end of the residual limb such that it contours the distal end ofthe limb to avoid skin irritation and provides shock absorption for theindividual user's residual limb. Item 19 is an example of a distal cupbefore it has been formed directly to match the individual's residuallimb. Item 10 is an example of the strut telescoping mechanism whereinthe height of the strut can be adjusted to match the needs of theindividual person.

FIG. 4 is a frontal cross sectional view of the above-knee(trans-femoral) prosthetic socket shown exploded in FIG. 3 after it hasbeen assembled and including a total surface-bearing flexible innerliner after it has been assembled and formed to the individual'sresidual limb. Item 39 in FIG. 4 is an example of an adjustable seam forthe directly formable wraparound longitudinal member of a directformable total surface-bearing flexible inner liner 44 which allows thewrap-around type longitudinal member of a direct formable totalsurface-bearing flexible inner liner 44 to be wrapped around thelongitudinal aspect of the limb and seal at an overlap for theappropriate circumference of the individual's residual limb after thedistal cup member for the direct formable total surface-bearing andflexible inner liner 47 has been formed. Item 44 is also meant to pointout the entirety of an assembled direct formable total surface-bearingflexible inner liner after it has been direct formed to match the sizeand contour of an individual's residual limb. Fabricating andengineering this directly formable wrap-around type longitudinal memberprovides the advantage that it can accommodate a wide array of limbshapes and sizes due to the wrap-around fitting method that itfacilitates. Item 40 is an example of a proximal tramline for thedirectly formable wrap-around type longitudinal member of a directformable total surface-bearing flexible inner liner 44 after it has beentrimmed to match the residual limb length and functional needs of theindividual's residual limb and after a non-abrasive and rolled edge hasbeen incorporated into this proximal trimline 40. Item 42 is an exampleof an inner and outer sealing member for the directly formablewrap-around type longitudinal member of a direct formable totalsurface-bearing flexible inner liner 44 after it has been direct formedto the individual's residual limb wherein the inner and outer sealingmember 42 aids in suspension of the residual limb. Item 43 is an exampleof an assembled modular prosthetic socket after the modular socketmembers have been selected and it has been assembled and then directformed to match the needs of the individual and the individual'sresidual limb wherein the individually selected modular socket membersof the modular prosthetic socket have been shown in an exploded view andindividually called out in FIG. 3. Item 45 is a distal sealing memberfor the directly formable wrap-around type longitudinal member for adirect formable total surface-bearing flexible inner liner 44 whereinthe distal seal allows for the directly formable wrap-around typelongitudinal member for a direct formable total surface-bearing flexibleinner liner 44 to be attached to and create an air-tight seal with thedirect formable distal cup member for the direct formable totalsurface-bearing and flexible inner liner 47 after they have beendirectly formed to fit the individual's residual limb. Item 48 is andirect formable distal end pad of the direct formable distal cup member47 that is fabricated and engineered to include means for direct formingto an individual's residual limb by allowing pre-filled air, foam,and/or other applicable contents to evacuate the sealed chamber by wayof an expulsion valve as the end pad is pressed onto the distal end ofthe residual limb for direct forming. If the distal end of the residuallimb gets smaller, air, foam, or other applicable material is allowed tore-enter the sealed chamber of the direct formable distal end pad 48passively through the expulsion valve or it is injected with applicablecontents until it meets the distal end of the amputee's residual limb.Therefore, this example of a direct formable distal end pad is not onlycustom shaped to the distal end of the individual's residual limb, it isalso a custom end pad that can change with the individual as their limbchanges with time. Item 49 is an example of an enclosed and assembledserrated channel with a distal portion of a strut is placed in theenclosed and assembled serrated channel 49 at the desired takeoff angle.Item 21 is an example of an assembled distal attachment member whereinthe distal attachment members shown here is fabricated and engineered tobe able to assemble in such a way that it can receive and securely mountthe distal aspect of a strut as well as a distal cup and modularalignment components. Item 52 is an example of a microprocessor unit,means of communication linking between other independent sensors andmicroprocessors, and internal sensors wherein it has been joined with arotary tensioning mechanism 12. This microprocessor unit andaccompanying sensors and means of communication 52 allows for collectionof data, communication of data, and interpretation of data that providesthe ability for automated control of socket tightening and loosening bymeans of the rotary tensioning mechanism 12 as well as coordinationbetween other microprocessors and/or sensors located in other places onthe modular prosthetic socket or within distal componentry such as aknee, foot, elbow, and/or hand. This communication with one or moreother microprocessor or sensors located on the modular prosthetic socketprovides the ability for coordinated tightening, loosening, or otherpressure profile changing means within different parts of the modularprosthetic socket such as the direct foldable flexible inner liner 44and the side-mounted ratcheting lanyard suspension mechanism 64. Thisability for the modular prosthetic socket to automatically tighten,loosen, or otherwise change its pressure profile and to do so in acoordinated way with different aspects of the allows for the modularprosthetic socket and direct formable flexible inner liner 44 toautomatically change its pressure profile to match the user'spreferences for specific activities such as sitting or running. Whilethis particular example uses a rotary tension unit 12 and tensioningcables 53, as the means of pressure profile change, other means ofpressure profile change are utilized to change the pressure profile suchas phase changing materials, rheo magnetic fluid materials, ratchetingdevice/s, pulley systems, by application of heating or electricalcurrent to reform or change material properties, and/or other applicablemeans. Item 54 is an example of a moisture evacuation channel/s and/orsuspension channel which is incorporated into the direct formable distalcup member 47 and direct formable distal end pad 48 to allow the modularprosthetic socket to be compatible with existing methods of suspensionsuch as shuttle locks and moisture management as well as allow forproprietary modular socket members which offer means of suspensionand/or moisture management. Item 55 is an example of an expulsion valvethat can be used to expel air or fluid and is integrated into themoisture evacuation channel/s and/or suspension channel 54. Item 57 isan example of valve or port that enables use of an elevated vacuumsystem. Item 58 is an example of a pull cord for a side-mountedratcheting lanyard suspension mechanism 64. Item 59 is an example ofratcheting teeth/tabs for a side-mounted ratcheting lanyard suspensionmechanism 64. Item 60 is an example of a housing unit for amicroprocessor controlled locking mechanism for a side-mountedratcheting lanyard suspension mechanism 64, sensors, and means ofcommunication with microprocessor 52 and/or other microprocessors. Item62 is an example of manual release button for the locking mechanism fora side-mounted ratcheting lanyard suspension mechanism 64. Item 63represents a socket exit port which allows the ratcheting lanyard toexit the modular prosthetic socket and feed into the microprocessorcontrolled locking mechanism 60. Item 64 represents the overallside-mounted ratcheting lanyard suspension mechanism and specificallypoints to where the side-mounted ratcheting lanyard suspension mechanism64 is bonded to the direct formable total surface-bearing flexible innerliner 44.

FIG. 5 is a top view of an example of a right above-knee (trans-femoral)prosthetic socket after the modular members have been selected,assembled, molded, but before it has been adjusted to fit over anindividual's residual limb. This perspective gives a clear view of anencircling tensioning member without microprocessor control. Item 26 inthis figure is an example of a heating coil which is embedded into thestrut in order to allow for electrical current to pass through theheating coil 26 for the purpose of temporarily or permanently changingthe properties of the strut. Item 14 shows two examples of a proximalbrim member specially fabricated and engineered for the lateral aspectof the proximal brim for an above-knee (trans-femoral) modularprosthetic socket before they have been formed directly to match theindividual's residual limb. Item 15 is an example of a proximal brimmember specially fabricated and engineered for the ischial aspect of theproximal brim for an above-knee (trans-femoral) modular prostheticsocket before it has been formed directly to match the individual'sresidual limb wherein it is engineered and fabricate to be able to formdirectly for ischial containment. Item 19 is an example of a distal cupin its prefabricated form before it has been formed directly to matchthe individual's residual limb. Item 22 is an example an encircling bandbefore it has been formed directly to match the individual's residuallimb. This particular section is an example a semi-rigid and formablefemale telescoping member of an encircling band before it has beenformed to the individual's residual limb. Item 23 is an example asemi-rigid and directly formable male telescoping member of theencircling band 22 before it has been formed directly to theindividual's residual limb. Item 24 is an example of an inside surfaceof a strut before it has been formed directly to match the contours ofan individual's residual limb and/or cut to an appropriate length forthe individual's residual limb. This inside surface of a strut member,24 includes a shock absorbing material such as silicone as well asincluding lateral wicking moisture channels. Like other modular surfacesmaterial additions, these surface materials are engineered for ease ofreplacement in order to provide simple methods to be able to addmaterials or components that offer specific properties or attributesthat are beneficial for the end user. Item 25 is an example of aproximal brim member specially fabricated and engineered for theanterior-lateral aspect of the proximal brim for an above-knee(trans-femoral) modular prosthetic socket before it has been formeddirectly to match the individual's residual limb. Item 38 is an exampleof a prefabricated direct formable distal end pad with a moistureevacuation channel/s and/or suspension channel 33 before it has beenformed to the distal end of the residual limb such that it contours thedistal end of the limb to avoid skin irritation and provides shockabsorption for the individual user's residual limb.

FIG. 6 is a perspective view of an example of a below-knee(trans-tibial) prosthetic socket. Item 65 in this figure is an exampleof a proximal-medial brim member of the trans-tibial modular socket.Item 67 in this figure is an example of a relief cut-out for the distaltibia in the distal base member of the trans-tibial modular socket. Item66 is a joining member between a medial strut member and proximal brimmember 65 that allows height and angular adjustment by use of slidingand wedging. Item 70 is an adjustable strut to distal cup attachmentmechanism. Item 35 is a standard alignable modular pyramid connectorthat is made to attach to the distal cup 69. Item 72 is a ratchetingadjustable member. Item 73 is the flared aspect of the posterior strutmember of the socket that is specifically designed for allowing for kneerange of motion.

FIG. 7 is a perspective view of an example of an above-elbow(trans-humeral) prosthetic. Items 78 and 79 are the humeral and forearmsections, respectively, of the prosthesis that are connected to themodular socket. Item 74 is a sliding joint that may be used to adjustanterior-posterior fit of the socket. Note the difference between thestrut 32 in FIG. 7 and adjustable telescoping strut 85 in FIG. 8,demonstrating the option of including strut member 85 that is adjustablein length via telescoping and strut 75 that may be cut to length but arethen a fixed length. Item 77 is an adjustable attachment member used toattach strut 75 to distal cup 80. Item 82 is a cross-strut member thatattaches to the anterior two struts of this modular prosthetic socket ina horizontal orientation with respect to the long axis of the amputatedhumerus bone for the purpose of optimizing biomechanical control inflexion of the amputated humerus bone.

FIG. 8 is a perspective view of the same prosthetic sock as seen in FIG.7, after the after the proximal brim member 83 of FIG. 7 has been moldedand trimmed to produce the formed and trimmed proximal brim member 83 ofFIG. 8 in order to allow for increased range of motion. Moreover, FIG. 8shows an example of the same modular socket as in FIG. 7 wherein anaddition of a horizontally oriented adjustment member 84 offers greateruser-adjustability by means to tighten or loosen the proximal brim andproximal aspects of the included telescoping strut 85. Adjustableproximal brim to strut attachment mechanism 87 has also been added forincreased adjustability as compared to the modular socket of FIG. 7.Hence, FIG. 8 in comparison with FIG. 7 offers an example of how modularsocket members can be added, changed, and/or adjusted to accommodate theneeds of the individual amputee.

FIG. 9 is a perspective view of an example of an above-knee(trans-femoral) modular prosthetic socket after it has been formed to anindividual's residual limb, this particular example having a cut-out inthe strut member that allows for an encircling band to sit flush. Item95 shows a cut-out in the strut member 94, which allows for theencircling band 88 to sit flush. The encircling band 88 serves as anadjustment member/tensioning member for the proximal brim of the modularprosthetic socket. Item 89 shows a proximal brim member for thelateral-posterior portion of the socket. Item 92 shows an adjustableattachment member which attaches a strut to the distal cup 93. Item 90shows a proximal brim member that is specialized to form an ischialweight-bearing seat.

FIG. 10 is a perspective view of an example of an above-knee(trans-femoral) modular prosthetic socket after it has been formed to anindividual's residual limb. Item 102 is an adjustable attachment memberwhich attaches strut member 103 to the distal cup 100. Item 97 is aproximal brim member designed and molded directly to the user for theanterior-medial area of the proximal brim. Item 98 is a proximal brimmember that is specially designed and molded directly to the user toaccommodate ischial containment control of the user's residual limb.Item 99 is a non-adjustable proximal brim member that connects theischial containment proximal brim member 98 to the anterior-medialproximal brim member 97.

FIG. 11 is a perspective view of an example of a prosthetic socket ofthe present invention. This drawing is an example of the same rightabove-knee socket shown in FIG. 10, only the none-adjustable proximalbrim member of figure has been replaced with adjustable proximal brimmembers 105 and 105. Item 107 shows an alternative means of affixing theadjustable attachment member which connects a strut to a distal cupwherein removable and recessed bolts are used.

FIG. 12 is a perspective drawing of an example of a prosthetic socket ofthe present invention. This drawing is an example of a below-elbowsocket, otherwise known as transradial prosthetic socket. Item 84 is anadjustment slot in proximal brim member 109 that allows foradjustability of the proximal brim member 109. Proximal brim member 109also has means for adjustable supercondular clamping which is used as ameans for support and suspension. Item 110 is a direct formabletotal-contact flexible inner liner which fits internally to the strutsand proximal brim members and interfaces with the residual limb toincrease pressure distribution. Item 115 is an adjustable attachmentmember. Item 112 is an attachment screw used as attachment means betweena strut and a proximal brim member. Item 113 is a distal cup and item114 is a distal attachment member.

FIG. 13 is a superior view of the distal cup of the Symes (an ankledisarticulation socket) modular prosthetic socket as also seen in sideview in FIG. 14. Item 118 is a relief contour area of the distal cup andItem 117 is a compressive contour in the distal cup. These are examplesthat represent the fact that all members are specially contoured anddesigned for their specific applications. Item 116 is a moistureevacuation channel built into the distal cup.

FIG. 14 is a side view of a prosthetic Symes socket (ankledisarticulation socket), showing, in particular, a height adjustablemember with option for angular change. This drawing is an example of aleft Symes socket, otherwise known as an ankle disarticulationprosthetic socket after the modular members have been selected,assembled, molded, and adjusted to fit over an individual's residuallimb. Item 128 is a height adjustable member with option for angularchange. Item 126 is a distal push-in suction socket distal silicone cup.Items 125 are set screws that lock in the distal silicone cup 126. Item122 is a relief for the fibular head on the residual limb of the amputee(not shown). Item 129 is a proximal brim member designed and molded tothe residual limb of the amputee for the medial proximal aspect of theproximal brim. Item 119 is a proximal brim member designed and molded tothe residual limb of the amputee for the patellar tendon area of theproximal brim. Item 120 is a proximal brim member designed and molded tothe residual limb of the amputee for the lateral proximal aspect of theproximal brim. Item 123 is an adjustable attachment member. Item 124 isa distal attachment member. Item 129 is a proximal brim member used forthe medial aspect of the socket. Item 127 is a strut formed and used forthe medial longitudinal axis aspect of this prosthetic socket.

FIG. 15 is a perspective view of an above-knee (trans-femoral) socketthat shows detail of a proximal brim with an adjustable section, as wellas an ischial seat extension. This perspective drawing is demonstratingthe opportunity for different members to be used and selected to matchthe needs of the individual. An adjustable encircling band 133 can beused to provide an adjustable proximal brim, or a fixed proximal brim130 may be chosen. Item 132 is an ischial seat extension fastened withadjustable screws 124 and including a shock absorbing silicone pad. Item135 is a cross-link member fixed to a strut by attachment means 134 and137 connecting between two struts for added strength and biomechanicalcontrol. The adjustable encircling band 133 is a proximal brim memberdesigned to allow for tensioning/adjustment of the proximal brimmembers. Item 128 is an attachment screw for added cross link member135. Item 138 shows a joining mechanism of the proximal aspect of astrut which receives the adjustable encircling band 133 and allows it tobe attached flush with the amputee's residual limb.

FIG. 16 is a perspective view of the distal portion of an above-knee(trans-femoral) prosthetic socket, showing detail related to anintegrated suspension mechanism, and modular alignment feature and asettable hinge. FIG. 16 shows the ability for integrated suspensionmethods, such as item 144, an exit member for a suspension pull bag andlocation for mounting a suction valve. FIG. 16 further shows additionalfeatures that may be integrated into the modular prosthetic socket ofthe present invention to match the needs of the patient, such asadjustable alignment mechanism 143 and adjustable and settable (can befixed at a desired position) hinges 139, 142, and 147. Item 140 is astrut. Item 145 is a bolt used as means for attachment of adjustable andsettable hinge 147 to the distal cup.

FIGS. 17 and 18 are lateral cross-section drawings of specialized,proprietary, modular, and adjustable connection members that arefabricated and designed for specific purposes and can be utilized forthe modular prosthetic sockets and methods described herein.

FIG. 17 shows lateral cross-section views of modular adjustable jointand hinge options, showing an option of utilizing wedges that may beremoved or replaced to change the desired angle. Item 150 of this figureshows a wedge that can be removed or replaced to change the desiredtake-off angle of strut 148 relative to distal cup 149 and secured inplace by attachment rivet 149.

FIG. 18 shows a hinge with setscrew, hinge cover, and strut wedge. FIG.18 shows a hinge 162 with set screw 160 and hinge cover 158.Additionally, FIG. 18 shows the ability to add a wedge 154 or filler pad154 to the strut itself 156.

FIG. 19 is a superior perspective view of modular adjustable jointratchet options that may be utilized for the prosthetic socket. Item 194is a lock and release lever that snaps into a holding slot 195. Theother numbered items are as follows: 190 is a means for the user to pulltension on the ratchet, 190 is the axis by which the lock and releaselever 194 rotates, 196 is the portion of the ratchet strap which hasholding slots 195 which can snap into the lock and release lever 194,198 is the portion of the ratchet strap which connects to 196 and doesnot have holding slots 195 but can transfer or hold tension for theratchet system. FIG. 16 shows a set screw 174 that can change the angleof the Y shaped strut 166 along with wedges such as wedge 168.

FIG. 20 shows an adjustable hinge with the additional features ofretainer members as well as having the entire set beam member being aseparate member that may be placed separately and set into place. FIG.21 shows an adjustable hinge similar to that of FIG. 20, with theadditional features of retainer members 218 and 222 as well as havingthe entire set beam member 216 being a separate member that may beplaced separately and set into place with elements 226 and 214. Oneadvantage of this design is that this hinge may be integrated into alamination wherein the center of the hinge may be blocked off using adummy up against the sealing segments 224.

FIG. 21 is a perspective view of an example of prosthetic socket havingan adjustable hinge member with microprocessor control. Item 250 showswhere the microprocessor and control mechanism for the ladder 252 islocated within the strut member 246 along with height adjustability ofthe strut 244. Proximal brim member 238 has been designed to allow foradjustability of strut members. Item 242 is a proximal brim memberdesigned for ischial weight-bearing. Item 248 is an attachment andhousing means for microprocessor control adjustable member. Item 254 isan adjustment strap member which along with adjustable member 240provides means for adjustment of the proximal brim circumference so thatthe end user is empowered to tighten and loosen their own prostheticsocket manually.

FIG. 22 is a perspective view of an example of a portion of a prostheticsocket having an adjustable member with microprocessor control. Thisfigure shows an alternative control method for a microprocessor hinge262 as compared with the microprocessor controlled hinge of FIG. 21.This control method uses a hydraulic or pneumatic piston 266 thatattaches to the strut at axis 268 in order to move the angle of thestrut 260 to a desired position. Item 264 is a housing mechanism for themicroprocessor and location of attachment to the distal member/s of amodular prosthetic socket. Item 260 is an adjustable height mechanism.Item 258 is a recessed portion of the strut to accommodate an encirclingring 256.

FIG. 23 is a perspective view of an example of a prosthetic sockethaving oval shaped struts 270 that extend past the socket and form acongruent pylon and foot system, representing an entire prosthesis. Item270 is a strut that serves as a strut for the socket as well ascontinuing down to form the keel of the foot thereby serving as analignment component and terminal device a congruent unit that is alsoform contoured to match the needs of the amputee.

FIG. 24 is the same illustration as FIG. 23, except that it shows theoption of having additional adjustment capabilities incorporated intothe struts 278 and the interface members 272, 276, and 288. More or lessadjustability may be required, depending on the amount of volumefluctuation the individual typically experiences. Item 278 is a strutmember with integrated adjustability. Item 286 is a height adjustabilitysegment. Items 284, 280, and 282 show how the strut members may becontoured to transition directly into a prosthetic foot, to improveenergy transfer and efficiency. Item 276 is an interfacing surface padattached to the inside surface of the strut 278. Item 288 is a distalcup. Item 272 is an interface pad specially designed for the patellartendon area of the socket. Item 274 is a proximal brim member for themedial aspect of the socket.

FIG. 25 depicts an embodiment similar to that in FIG. 23, except that itdemonstrates with an outline that there is the option of having theentire modular prosthesis covered with a cosmetic covering or fairing288. Such a cosmetic cover or fairing 288 may be made of various typesof materials and may achieve various objectives, such as protecting theinner parts or simply providing a stylish aesthetic. The cover orfairing 288 may be made as a custom or prefabricated addition.

FIG. 26 is a perspective view of a prefabricated wrap-around cosmeticcover 290. This example may be made of a thin, light, water resistant,and low-cost material such as polyethylene, and may easily be wrappedaround, trimmed, and fixed to the finished prosthesis.

FIG. 27 is a perspective view of oval shaped struts 294 and 300, Yconnecting joint member 298, proximal brim member 292, and proximal brimconnector 296. These members make up a hypothetical example of modularmembers that may be selected and utilized for the lateral-proximalaspect of a trans-tibial prosthesis.

FIG. 28 is a perspective drawing of an oval shaped strut member. Item306 is the convex surface, designed for comfortable weight distribution,showing the rounded ends 308 that avoid any sharp edges. Item 302 is ahollow, solid, or filled core, depending on the needs.

FIG. 29 is a perspective drawing of an oval shaped strut member 304 withcontour and transverse plane rotation 304. Adjustability may come fromthe material used and/or from the mechanical design, and may remainflexible or be set rigid.

FIG. 30 is a lateral perspective of an oval shaped strut member 304 withcontour and with adjustable interface member 310. Item 314 is an exampleof a set screw that may be used to tighten or loosen the compression ofthe interface member 310. Access 312 to the set screws 314 allows foreasy adjustment by the user or the practitioner. A modular andadjustable interface member such as this may be applied to differentmembers of the socket and may be utilized in various types of modularmethod sockets, as well as in other applications previously mentioned,such as orthotics, robotics, and exoskeletal applications.

FIG. 31 is a flow chart showing an example of the steps involved inproviding a prosthetic limb for an individual by the method for fittinga modular prosthetic socket according to the present invention. In step1 of this example, an evaluation of the individual with amputation ispreformed wherein the evaluation includes questions and assessment thatlead one trained in the field to be able to determine the activity levelas well as gather the typical and desired acts of daily living for theindividual with amputation. This information is important in ensuringthat the modular prosthetic socket will be assembled with componentsthat reflect the activity level of the individual and will facilitatethe specific tasks and activities the individual performs or aims toperform. Step 2 includes weighing the individual and measuring thedimensions and shape of the individual's residual limb in selectpositions within the limb's range of motion. Step 2 is preformed inorder to establish the size and contours of the residual limb throughdifferent positions in the limb's range of motion. The individual isweighted because it is important that the selected modular socketmembers are weight rated high enough for the individual's weight andactivity level. Other evaluation parameters include; manual muscletesting, range of motion, skin condition, health history, allergies,sensitive areas or aspects to the residual limb, expectations andconcerns, cosmetic preferences, therapy history and plan, psychologicalwellbeing, living condition, and other appropriate evaluationparameters. In step 3 socket members are selected from modular componentinventories for their appropriateness with respect to the evaluation,measurements, and observation preformed in steps 1 and 2 wherein thecomponent inventories are inventories that are separated by level ofamputation and may include variation with respect to length, width,contour, flexibility, elastic modulus, durometer, formability,re-formability, adjustability, and other variation. For example, whenfitting an individual who has had a trans-radial amputation one wouldrefer to a modular prosthetic component kit that is specific totrans-radial level amputation wherein the kit includes struts of variouswidth and weight ratings as determined by their strength, distal cups ofvarious diameter, and various proximal brim styles. In step 4 themodular members that have been selected for the individual are to beassembled in such a way that is reflective of what has been learned ofthe individual during evaluation steps 1 and 2. For example, twodifferent individuals may be indicated for the same modular prostheticsocket components but require different assembly of those componentsthat is indicative of differences in their limb contour such that oneindividual's limb contours more gradually and the other's is moreabrupt. In step 5 the socket is socket is connected to distal componentsof the prosthesis. This step would be eliminated in versions of thepresent invention where the distal components are integrated into thesame cohesive unit as the modular socket members as shown in FIGS.23-25. In step 6 the assembled modular prosthetic socket are trieddirectly onto the residual limb as a ‘test’ fitting wherein this isconsidered a ‘test’ in that it is expected that adjustments and changeswill likely be required to optimize the fit and biomechanical controlfor the individual. The ‘test’ fitting of step 6 may be a static fitting(without motion of the limb) or a dynamic fitting (where the limb istested in motion as well as static) depending on how good the test fitis and the capabilities of the individual with the test fit socket. Instep 7 the limb is protected with a thermal barrier. This step isapplicable when a direct forming technique that is exothermic orthermoforming is to be utilized to direct mold the socket members overthe individual's residual limb in steps to follow. A thermal barrier maybe used as a precautionary measure even though materials may even besafe directly against the skin during thermoforming. In step 8 one ormore of the members included in the modular prosthetic socket are directformed over the residual limb of the individual wherein the directfitting process may include positive pressure or negative pressure fromone or more molding aid devices, use of a specialized jig, computeraided, other assistive devices, and/or from manually forming member/s tothe individuals residual limb by hand. For example, a wrap-around andsealing suction molding member may be used that can wrap around and sealfor a large variety of individuals and is transparent such that onetrained in the field can still manually influence the shape of themolding by hand over the molding member. In step 9 the modularprosthetic socket is donned and used dynamically while furtherevaluation is used to determine any changes that are required to themodular prosthetic socket or to the prosthesis as a whole. Evaluation ofthe fit and function of the prosthesis can be done manually throughmethods in the field and/or with the aid of computer analysis which mayinclude temporarily inserted force sensors in the socket or permanentlyintegrated force sensors. Step 10 represents the start of ensuring thatthe individual is trained in care of the prosthesis, proper use of theprosthesis, and necessary follow-up for the prosthesis. This trainingmay include referrals or internal cooperation with other healthcareprofessionals such as physical and occupational therapists to aid intraining and rehabilitation for the individual.

The above description is included to illustrate the operation ofpreferred embodiments, and is not meant to limit the scope of theinvention. The scope of the invention is limited only by the followingclaims. From the above discussion, many variations will be apparent toone skilled in the art that would yet be encompassed by the spirit andscope of the present invention.

What is claimed is:
 1. A modular prosthetic socket for a residual limbof a human extremity for use with a modular endoskeletal distalcomponent, the socket comprising: a) at least two longitudinal struts,each of the struts having a non-circular cross-sectional shape, eachstrut having proximal and distal ends; b) a distal base having aproximal aspect and a distal aspect, the base assembled in fixedrelation to the struts and adapted to couple the struts to the modularendoskeletal distal component; and c) a distal cup positioned at theproximal aspect of the base, the distal cup having a tapered, concaveinterior at its distal end, the distal end smaller than the base andadapted to receive the residual limb.
 2. The modular prosthetic socketof claim 1, wherein: the struts have an interior aspect facing radiallyinward and an exterior aspect facing radially outward, and the strutsare rotatable relative to the base such that the interior aspect may beangularly displaced.
 3. The modular prosthetic socket of claim 1,wherein: the struts have an interior aspect facing radially inward andan exterior aspect facing radially outward, a portion of the interioraspect of the struts facing the distal cup.
 4. The modular prostheticsocket of claim 1, wherein: at least one of the struts is adjustable inlength.
 5. The modular prosthetic socket of claim 1, wherein: all of thestruts are attached to the base.
 6. The modular prosthetic socket ofclaim 1, wherein: the at least two struts consists of four struts. 7.The modular prosthetic socket of claim 1, further comprising: a shockabsorbing material, wherein the struts have an interior aspect facingradially inward and an exterior aspect facing radially outward and theshock absorbing material is provided to the interior aspect of one ormore struts.
 8. The modular prosthetic socket of claim 1, furthercomprising: a plurality of separable brims coupled over proximal ends ofat least two of the struts.
 9. The modular prosthetic socket of claim 8,further comprising: a flexible band extending between and/or around atleast two brims.
 10. The modular prosthetic socket of claim 1, furthercomprising: a flexible band extending between and/or around at least twostruts.
 11. The modular prosthetic socket of claim 1, wherein: the atleast two struts have a common attachment mechanism to fix the strutsrelative to the base, but the struts have variations in dimension and/orshape from each other.
 12. The modular prosthetic socket of claim 1,wherein: the struts are made of a moldable thermoplastic material. 13.The modular prosthetic socket of claim 1, wherein: the struts are madeof a thermoplastic resin and carbon fibers.
 14. A modular prostheticsocket for a residual limb of an amputee, the socket for use with amodular endoskeletal distal component, the socket comprising: a) atleast two longitudinal struts, each of the struts having a non-circularcross-section and proximal and distal ends; b) a distal base couplingthe distal ends of the struts relative to the modular endoskeletaldistal component; and c) an element coupled to the base to directlysupport a garment worn by the amputee over the residual limb.
 15. Themodular prosthetic socket of claim 14, wherein: at least one of thestruts is adjustable in length.
 16. The modular prosthetic socket ofclaim 14, further comprising: a flexible band extending between and/oraround at least two struts.
 17. The modular prosthetic socket of claim14, wherein: the struts are made of a moldable thermoplastic materialand optionally carbon fibers.
 18. A modular prosthetic socket for aresidual limb of an amputee, the socket for use with a modularendoskeletal distal component, the socket comprising: a) a plurality oflongitudinal struts, each of the struts having a non-circularcross-section and proximal and distal ends; b) a distal base forcoupling to the modular endoskeletal distal component, at least two ofthe struts fixed in relation to the base to define an interior aspectand an exterior aspect; and c) at least one first element positioned onat least the interior aspect of the proximal end of the at least twostruts, the at least one element softer than the struts.
 19. The modularprosthetic socket of claim 18, further comprising: a second elementcoupled to the base to directly support a garment worn by the amputeeover the residual limb.
 20. The modular prosthetic socket of claim 18,wherein: at least one of the struts is adjustable in height relative tothe distal base.
 21. The modular prosthetic socket of claim 18, furthercomprising: a first band extending between and/or around at least twostruts.
 22. The modular prosthetic socket of claim 21, wherein: thefirst band includes: a first portion, a second portion, at least onetensioning element that couples the first and second portions together,and a mechanism that permits loosening or tightening of the at least onetensioning element to adjust tension in the first band.
 23. The modularprosthetic socket of claim 18, wherein: the at least one first elementcomprises brim members removably fitted onto the struts.
 24. The modularprosthetic socket of claim 23, further comprising: a second bandextending between and/or around at least two brim members.
 25. Themodular prosthetic socket of claim 18, wherein: the struts are made of amoldable thermoplastic material and optionally carbon fibers.
 26. A kitfor assembly of a modular prosthetic socket for use on a residual limbof an amputee, the socket for use with a modular endoskeletal distalcomponent, the kit comprising: a) a plurality of longitudinalheat-moldable struts; b) a distal base having structure for coupling tothe modular endoskeletal distal component, the plurality of strutscouplable in fixed relationship relative to a periphery of the distalbase; c) a plurality of first elements positionable on at least theinterior aspect of the proximal end of the struts, the first elementsprovided in multiple sizes and/or shapes, the first elements softer thanthe struts; and d) at least one banding element for extension betweenand/or around the plurality of longitudinal struts when the struts arein the fixed relationship relative to the periphery of the distal base.27. The kit according to claim 26, wherein: at least one strut islength-adjustable.
 28. The kit according to claim 26, wherein: each ofthe struts has a non-circular cross-section and proximal and distalends, a length extending between the proximal and distal ends, and awidth, and the first elements are wider than the width of the struts.29. The kit according to claim 26, wherein: the plurality of struts arein at least two different lengths.
 30. The kit according to claim 26,further comprising: a distal cup positioned at a proximal aspect of thebase, the distal cup having a tapered, concave interior at its distalend, the distal end smaller than the base and adapted to receive theresidual limb.